Seaspine, Inc.
Medical device manufacturer in Carlsbad, CA.
33510(k) clearances
0PMA approvals
11recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 6
- MAX Intervertebral Fusion Device With Bone… 5
- KWQ Appliance, Fixation, Spinal Intervertebral… 4
- MNI Orthosis, Spinal Pedicle Fixation 3
- KWP Appliance, Fixation, Spinal Interlaminal 3
- MQP Spinal Vertebral Body Replacement Device 2
- NQW Orthosis, Spine, Plate, Laminoplasty, Metal 2
- OVD Intervertebral Fusion Device With… 1
- ODP Intervertebral Fusion Device With Bone… 1
- OVE Intervertebral Fusion Device With… 1
- ETN Stimulator, Nerve 1
- PEK Spinous Process Plate 1
- MRW System, Facet Screw Spinal Device 1
- MQV Filler, Bone Void, Calcium Compound 1
- NKG Posterior Cervical Screw System 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K231654 | NorthStar OCT SystemNKG · Traditional | 08/03/2023SE |
| K212135 | Dry DBM- A PuttyMQV · Traditional | 10/04/2021SE |
| K150469 | Integra Laminoplasty SystemNQW · Special | 03/23/2015SE |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…MAX · Traditional | 12/18/2014SE |
| K133418 | Integra Expandable Interverebral Body Fusion Device (Ibd) SystemMAX · Traditional | 05/01/2014SE |
| K132859 | Integra Facet Fixation SystemMRW · Traditional | 11/18/2013SE |
| K121924 | Integra Interspinous Process SystemPEK · Traditional | 09/04/2013SE |
| K130830 | Integra Laminoplasty SystemNQW · Traditional | 05/09/2013SE |
| K122571 | Malibu Spinal System with the Daytona Deformity SystemNKB · Special | 12/12/2012SE |
| K112206 | Cardiff Anterior Cervical Plate SystemKWQ · Special | 01/25/2012SE |
| K111671 | Seaspine Monopolar Probe SysyemETN · Traditional | 12/28/2011SE |
| K102026 | Seaspine Spacer SystemMAX · Traditional | 05/12/2011SE |
| K103297 | Redondo-LMAX · Special | 01/27/2011SE |
| K092521 | Zuma-COVE · Traditional | 04/13/2010SE |
| K082309 | CambriaODP · Traditional | 04/09/2009SE |
| K083338 | Cardiff Anterior Cervical Plate SystemKWQ · Traditional | 02/02/2009SE |
| K083089 | Newport Spinal SystemNKB · Traditional | 01/13/2009SE |
| K082926 | Zuma, Model 55-XXXX/56-XXXXOVD · Traditional | 12/22/2008SE |
| K082310 | Hollywood, Pacifica, Redondo, VenturaMAX · Traditional | 11/10/2008SE |
| K072729 | SierraKWP · Special | 04/17/2008SE |
| K080526 | Sierra SystemKWP · Special | 04/16/2008SE |
| K072605 | Malibu Spinal SystemNKB · Traditional | 12/20/2007SE |
| K071726 | ZumaMQP · Traditional | 10/23/2007SE |
| K062934 | SierraMNI · Traditional | 11/16/2006SE |
| K061342 | Malibu Spinal SystemNKB · Traditional | 10/25/2006SE |
| K052170 | Seaspine VBR SystemMQP · Traditional | 12/21/2005SE |
| K051942 | Malibu Spinal SystemKWP · Traditional | 07/27/2005SE |
| K051663 | Malibu Spinal SystemNKB · Traditional | 07/12/2005SE |
| K043232 | Ucr Spinal SystemNKB · Traditional | 12/21/2004SE |
| K040130 | Anterior Lumbar Buttress SystemKWQ · Traditional | 03/26/2004SE |
| K032739 | Ucr Spinal SystemMNI · Special | 11/20/2003SE |
| K032368 | Sonoma Anterior Cervical Plate SystemKWQ · Traditional | 10/09/2003SE |
| K031381 | Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and InstrumentsMNI · Traditional | 07/30/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1841-2014 Class II | Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical…Integra has identified through an investigation of complaints that there may be the potential for the tip of… | 05/21/2014Terminated |
| Z-1927-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |
| Z-1926-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 45mm Part Number 13-6545 Malibu Spinal System…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |
| Z-1925-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540 Malibu Spinal System…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |
| Z-1924-2009 | Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |
| Z-1923-2009 | Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |
| Z-1922-2009 | Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |
| Z-1921-2009 | Malibu Polyaxial Screw, 6.5 x 45mm Part Number 12-6545 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |
| Z-1920-2009 | Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |
| Z-1919-2009 | Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |
| Z-1918-2009 | Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | 03/04/2009Terminated |