Ebi, L.P.
Medical device manufacturer in Parsippany, NJ.
95510(k) clearances
1PMA approvals
42recalls
Device types
- KTT Appliance, Fixation, Nail/Blade/Plate… 35
- KWQ Appliance, Fixation, Spinal Intervertebral… 10
- NKB Thoracolumbosacral Pedicle Screw System 10
- MNH Orthosis, Spondylolisthesis Spinal Fixation 6
- HRS Plate, Fixation, Bone 6
- MQP Spinal Vertebral Body Replacement Device 6
- MNI Orthosis, Spinal Pedicle Fixation 4
- MAX Intervertebral Fusion Device With Bone… 3
- MQV Filler, Bone Void, Calcium Compound 2
- BSO Catheter, Conduction, Anesthetic 2
- NDF Plate, Fixation, Bone, Non-Spinal, Metallic 2
- HAW Neurological Stereotaxic Instrument 2
- HRX Arthroscope 2
- KWP Appliance, Fixation, Spinal Interlaminal 1
- LXT Appliance, Fixation, Nail/Blade/Plate… 1
- HWC Screw, Fixation, Bone 1
- HSB Rod, Fixation, Intramedullary And Accessories 1
- NDN Cement, Bone, Vertebroplasty 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K100438 | Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemNKB · Special | 06/23/2010SE |
| K100220 | Polaris Spinal SystemNKB · Special | 05/17/2010SE |
| K093880 | Peanut Growth Control Plating SystemHRS · Traditional | 04/16/2010SE |
| K092574 | Esl Spinal SystemMAX · Traditional | 02/04/2010SE |
| K093057 | Biomet Vision Footring SystemKTT · Traditional | 12/01/2009SE |
| K092336 | C-Thru Spinal SystemMQP · Traditional | 10/15/2009SE |
| K091381 | Ibex Spinal SystemMAX · Traditional | 08/07/2009SE |
| K090203 | 5.5 Helical Flange Spinal System, Polaris ComponentsNKB · Special | 07/30/2009SE |
| K090523 | Polaris Spinal SystemNKB · Traditional | 07/01/2009SE |
| K082406 | Expandable Peek-Optima ImplantMAX · Traditional | 01/14/2009SE |
| K082187 | Biomet Anterior Lumbar PlateKWQ · Traditional | 11/13/2008SE |
| K063346 | Pro Osteon 500RMQV · Traditional | 04/18/2007SE |
| K062494 | Ebi Optilock Upper Extremity Plating SystemHRS · Traditional | 10/19/2006SE |
| K062810 | Solitaire Anterior Spinal SystemMQP · Special | 10/17/2006SE |
| K062685 | Ebi Aray Spinal SystemNKB · Special | 10/06/2006SE |
| K061978 | Ebi, L.P.'S Line Extension to the Array Spinal SystemMNI · Special | 08/11/2006SE |
| K061441 | Ebi 5.5 Helical Flange Spinal SystemMNH · Traditional | 07/25/2006SE |
| K061563 | Ebi Array Spinal SystemNKB · Special | 06/23/2006SE |
| K061016 | Ebi Esl Peek-Optima Spine SystemMQP · Special | 06/08/2006SE |
| K061098 | Ebi Optilock Periarticular Plating SystemHRS · Traditional | 05/24/2006SE |
| K060148 | Ebi Vertebroplasty SystemsNDN · Traditional | 03/13/2006SE |
| K060379 | Ebi Anterior Cervical Plate SystemKWQ · Traditional | 03/06/2006SE |
| K052239 | Ebi Dynafix Vision Footplate SystemKTT · Traditional | 09/21/2005SE |
| K051724 | Acumen Image Guided Surgical SystemHAW · Traditional | 07/19/2005SE |
| K050118 | Ebi Trochanteric Nail SystemHSB · Traditional | 02/16/2005SE |
| K042772 | Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation DeviceNKB · Traditional | 12/13/2004SE |
| K042268 | Ebi Cas Spine Spacer SystemMQP · Special | 10/27/2004SE |
| K042237 | Ebi Periarticular Plating SystemHRS · Traditional | 09/16/2004SE |
| K033918 | Ebi Lactosorb Graft Containment SystemHRS · Traditional | 08/16/2004SE |
| K040935 | Ebi Xfix DFS SystemKTT · Traditional | 07/06/2004SE |
| K040908 | Ebi Distal Radius Plating SystemHRS · Traditional | 06/25/2004SE |
| K040833 | Modification to Ebi Xfix Vision Fixation SystemKTT · Special | 04/29/2004SE |
| K040482 | Ebi Esl Spine Spacer SystemMQP · Traditional | 04/16/2004SE |
| K033312 | Ebi Top Loading Mas Spinal Fixation SystemNKB · Traditional | 01/13/2004SE |
| K033635 | Modification to Ebi Xfix Vision Fixation SystemKTT · Special | 12/03/2003SE |
| K031732 | Ebi Acumen Surgical Navigation SystemHAW · Traditional | 10/15/2003SE |
| K031919 | Ebi Xfix DFS SystemKTT · Traditional | 09/04/2003SE |
| K032390 | Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter SystemBSO · Special | 08/29/2003SE |
| K031354 | Ebi OMEGA21 Spinal Fixation SystemMNI · Traditional | 08/06/2003SE |
| K031424 | Ebi Spinelink Spinal Fixation SystemNKB · Traditional | 07/22/2003SE |
| K031355 | Ebi Spinelink - II Spinal Fixation SystemNKB · Traditional | 07/22/2003SE |
| K031093 | Ebi Xfix Optirom Knee FixatorKTT · Traditional | 07/10/2003SE |
| K031423 | Ebi P148 Spinal Fixation SystemMNH · Traditional | 06/27/2003SE |
| K031645 | Ebi Xfix DFS SystemKTT · Special | 06/25/2003SE |
| K030706 | Ebi Dynafix Compression Bone ScrewHWC · Traditional | 03/20/2003SE |
| K030372 | Modification to Ebi Dynafix Diaphyseal Correction SystemKTT · Traditional | 03/06/2003SE |
| K024248 | Modification to Ebi Xfix DFS System Metaphyseal Correction SystemKTT · Special | 01/22/2003SE |
| K024129 | Modification to Ebi Xfix DFS SystemKTT · Special | 01/15/2003SE |
| K023233 | Ebi Targetcath Fluoro-Guided Steerable Catheter SystemBSO · Traditional | 12/13/2002SE |
| K023399 | Ebi Xfix DFS SystemKTT · Special | 10/25/2002SE |
| K023324 | Modification to Ebi Xfix DFS SystemKTT · Special | 10/18/2002SE |
| K023204 | Modification to Ebi OMEGA21 Spinal Fixation SystemMNH · Special | 10/18/2002SE |
| K023133 | Modification to Ebi Vuelock Anterior Cervical Plate SystemKWQ · Special | 10/18/2002SE |
| K022419 | Ebi Spinelink Anterior Cervical Spinal SystemKWQ · Special | 08/12/2002SE |
| K022319 | Ebi Xfix DFS SystemKTT · Special | 08/12/2002SE |
| K021749 | Ebi Dynafix VS Osteotomy SystemNDF · Traditional | 08/12/2002SE |
| K021695 | Ebi Dynafix Diaphyseal Correction SystemKTT · Special | 06/20/2002SE |
| K021312 | Ebi DFS Optirom Elbow FixatorKTT · Special | 05/23/2002SE |
| K021031 | Ebi Xfix Rail SystemKTT · Traditional | 05/16/2002SE |
| K020887 | Ebi Ais Spine SystemMQP · Traditional | 05/16/2002SE |
| K021091 | Ebi Xfix DFS SystemKTT · Special | 05/03/2002SE |
| K020681 | Ebi OMEGA21 Spinal Fixation SystemMNH · Special | 04/03/2002SE |
| K020403 | Modification to Ebi Xfix DFS Optirom Elbow FixatorKTT · Special | 03/08/2002SE |
| K014276 | Modification to Ebi Xfix DFS SystemKTT · Special | 03/01/2002SE |
| K020141 | Modification to Ebi Xfix Vision Fixation SystemKTT · Special | 02/05/2002SE |
| K014194 | Modification to Ebi Xfix Vision Fixation SystemKTT · Special | 01/17/2002SE |
| K014137 | Modification to Ebi Omega 21 SystemMNH · Special | 01/16/2002SE |
| K013739 | Modification to Ebi Xfix DFS SystemLXT · Special | 12/13/2001SE |
| K012516 | Ebi Spinelink - II Spinal Fixation SystemKWP · Traditional | 11/27/2001SE |
| K013540 | Ebi Xfix Access Pelvic FixatorKTT · Special | 11/20/2001SE |
| K013378 | Ebi Xfix DFS SystemKTT · Special | 11/08/2001SE |
| K011386 | Ebi Osteostim Granules-Resorbable Bone Graft SubstituteMQV · Traditional | 08/03/2001SE |
| K012024 | Ebi Xfix DFS SystemKTT · Special | 07/25/2001SE |
| K011711 | Modification to Ebi Efix Vision Fixation SystemKTT · Special | 06/29/2001SE |
| K011697 | Ebi Xfix Access Pelvic FixatorKTT · Special | 06/27/2001SE |
| K010551 | Ebi Dynafix VS Osteotomy SystemNDF · Traditional | 05/17/2001SE |
| K010437 | Modification to Ebi Xfix DFS Rail SystemKTT · Special | 03/13/2001SE |
| K010179 | Ebi Vuecath Spinal Endoscopic SystemHRX · Special | 02/09/2001SE |
| K010003 | Ebi Vuelock Anterior Cervical Plate SystemKWQ · Special | 01/31/2001SE |
| K003898 | Ebi Vuecath Spinal Endoscopic SystemHRX · Special | 01/04/2001SE |
| K003764 | Modification to Ebi Spinelink SystemMNH · Special | 01/02/2001SE |
| K002980 | Modification to Ebi Anterior Cervical Plate SystemKWQ · Special | 10/23/2000SE |
| K001357 | Modification to Omega 21 SystemKWQ · Traditional | 07/20/2000SE |
| K001794 | Ebi Anterior Cervical Plate SystemKWQ · Special | 07/12/2000SN |
| K001358 | Ebi Xfix DFS Metaphyseal Correction SystemKTT · Special | 05/23/2000SE |
| K001037 | Modification to Ebi Spinelink SystemMNI · Special | 04/14/2000SE |
| K000513 | Modification to Ebi Spinelink Anterior Cervical Spinal SystemKWQ · Special | 03/07/2000SE |
| K000319 | Ebi Xfix DFS SystemKTT · Special | 02/25/2000SE |
| K000083 | Ebi Xfix DFS Rail SystemKTT · Special | 02/03/2000SE |
| K993886 | Ebi Xfix Vision Fixation SystemKTT · Special | 12/14/1999SE |
| K993822 | Ebi Spinelink Anterior Cervical Spinal SystemKWQ · Special | 12/10/1999SE |
| K992920 | Ebi Spinelink SystemMNI · Traditional | 11/23/1999SE |
| K993649 | Ebi Xfix DFS Wristfix SystemKTT · Special | 11/19/1999SE |
| K992515 | Ebi Xfix DFS Optirom Elbow FixatorKTT · Special | 08/17/1999SE |
| K970290 | Ebi X Fix Dynafix Mini External Fixation SystemKTT · Traditional | 04/01/1997SE |
PMA approvals
- P820008 Scolitron(Tm) Stimulator · 01/06/1983 · 5 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2312-2009 | Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; Biomet Spine, Parsippany, NJ…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2311-2009 | Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System; Made…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2310-2009 | Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System Made…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2309-2009 | Fixed Closed Screw (Ti); 6.0MM (D) x 40 MM (L) Made In USA, Biomet Spine, Parsippany, NJ…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2308-2009 | Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA, Biomet Spine, Parsippany, NJ…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2307-2009 | Fixed Open Screw (TI); 7.0MM (D) x 30MM (L); Made In USA, Biomet Spine, Parsippany, NJ…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2306-2009 | Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; Biomet Spine, Parsippany, NJ The…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2305-2009 | Pediatric Femoral Nail 5.5MM (d) x 36 CM (L) Rx only, Sterile; Biomet, 100 Interpace…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2304-2009 | Pediatric Femoral Nail 5.5MM (d) x 32 CM (L) Rx only, Sterile; Biomet, 100 Interpace…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2303-2009 | Pediatric Femoral Nail 5.5MM (d) x 30 CM (L) Rx only, Sterile; Biomet, 100 Interpace…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2302-2009 | Pediatric Femoral Nail 5.5MM (d) x 28 CM (L) Rx only, Sterile; Biomet, 100 Interpace…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2301-2009 | C-Tek Maxan Anterior Cervical Plate System; 4.0MM X 20MM Fixed Screw' Biomet Spine, 100…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2300-2009 | Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM; Biomet Spine…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2299-2009 | Bone Screw4.5MM X 95MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2298-2009 | Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2297-2009 | Bone Screw .5MM X 60MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2296-2009 | Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2295-2009 | Bone Screw 4.5MM X 36MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2294-2009 | Bone Screw 4.5MM X 28MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2293-2009 | Bone Screw 4.5MM X 20MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2292-2009 | Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2291-2009 | Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2290-2009 | Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2289-2009 | TI Screw Buttress Thread 6MM (D) x 65MM (L) Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2288-2009 | TI Screw Buttress Thread 5MM (D) x 35MM (L) Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2287-2009 | TI Cannulated Screw 32MM thrd 7.3MM (d) X 120MM (L); Trauma Fixation Systems, Rx Only…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2286-2009 | TI Cannulated Screw 32MM thrd 7.3MM (d) X 100MM (L); Trauma Fixation Systems, Rx Only…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2285-2009 | TI Cannulated Screw 32MM thrd 7.3MM (d) X 95MM (L); Trauma Fixation Systems, Rx Only…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2284-2009 | TI Cannulated Screw 20MM thrd 6.5MM (d) X 85MM (L); Trauma Fixation Systems, Rx Only…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2283-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2282-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2281-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2280-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2279-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2278-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2277-2009 | TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; Biomet…Some devices could have been made with raw material lots that may have inclusions, and could result in… | 04/02/2009Terminated |
| Z-2116-2009 | Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx…Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices. | 03/27/2009Terminated |
| Z-2115-2009 | Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems…Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices. | 03/27/2009Terminated |
| Z-2012-2008 | Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument…Customer complaint received regarding the separation of the mallet handle during a medical procedure. | 05/07/2008Terminated |
| Z-0825-2008 | OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm.…Unapproved Testing: Tissue supplier (LifeLink) utilized unapproved diagnostic testing on certain lots of… | 10/23/2007Terminated |
| Z-0181-2007 | VHS Pediatric Plate (for hip screw system) Ref 200501, VHS Pediatric Plate Stainless…VHS Plate and lag screw components did not assemble correctly intraoperatively. | 09/06/2006Terminated |
| Z-0180-2007 | VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx onlyVHS Plate and lag screw components did not assemble correctly intraoperatively. | 09/06/2006Terminated |