Theken Spine, LLC
Medical device manufacturer in Medina, OH.
23510(k) clearances
0PMA approvals
5recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 6
- MQP Spinal Vertebral Body Replacement Device 3
- OVD Intervertebral Fusion Device With… 3
- KWP Appliance, Fixation, Spinal Interlaminal 2
- KWQ Appliance, Fixation, Spinal Intervertebral… 2
- MAX Intervertebral Fusion Device With Bone… 2
- MNI Orthosis, Spinal Pedicle Fixation 2
- OVE Intervertebral Fusion Device With… 1
- ODP Intervertebral Fusion Device With Bone… 1
- HRX Arthroscope 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K121482 | Instrument System for Endoscopic Spinal SurgeryHRX · Traditional | 08/28/2012SE |
| K121211 | Vu Apod Intervertebral Body Fusion DeviceOVD · Special | 06/27/2012SE |
| K120829 | Stainless Steel Spinal SystemNKB · Special | 05/30/2012SE |
| K120047 | Coral Spinal SystemNKB · Special | 02/03/2012SE |
| K111675 | Vu C*Pod Intervertebral Body Fusion DeviceODP · Special | 08/02/2011SE |
| K103228 | Paramount R Ibf DeviceMAX · Special | 01/05/2011SE |
| K102323 | Cervical Standalone Intervertebral Body Fusion DeviceOVE · Traditional | 12/16/2010SE |
| K101310 | Vu Apod Intervertebral Body Fusion DeviceOVD · Traditional | 09/02/2010SE |
| K100970 | Stainless Steel Spinal SystemNKB · Traditional | 08/12/2010SE |
| K091266 | Theken Coral Spinal SystemNKB · Special | 06/10/2009SE |
| K083863 | Theken Atoll Oct Spinal SystemMNI · Traditional | 03/27/2009SE |
| K083073 | Theken Atoll Cervico-Thoracic SystemMNI · Special | 03/13/2009SE |
| K082712 | Theken Spine Vu Epod and Vu Lpod SystemMAX · Traditional | 01/02/2009SE |
| K080822 | Vu Apod Intervertabral Body Fusion DeviceOVD · Traditional | 07/02/2008SE |
| K081414 | Modification to Coral Spinal SystemNKB · Special | 06/17/2008SE |
| K080790 | Modification to Theken Atoll Cervico-Thoracic SystemKWP · Special | 04/29/2008SE |
| K080690 | Manta Ray Anterior Cervical Plate SystemKWQ · Traditional | 04/25/2008SE |
| K072407 | Bodyform Thoracic Fixation SystemKWQ · Traditional | 12/21/2007SE |
| K070962 | Coral Pedicle Screw SystemNKB · Special | 08/22/2007SE |
| K071031 | Vu E*Pod Vertebral Body ReplacementMQP · Traditional | 07/30/2007SE |
| K070786 | X-Pod Adjustable Vertebral Body ReplacementMQP · Traditional | 06/28/2007SE |
| K070638 | Theken Atoll Cervico-Thoracic SystemKWP · Traditional | 05/30/2007SE |
| K070381 | Theken Vu Mesh VBR SystemMQP · Traditional | 04/25/2007SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0169-2011 | Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered…The firm's quality control testing determined that a separation was occurring between the flowable carrier… | 08/26/2010Terminated |
| Z-0087-2011 | Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the…The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints… | 07/29/2010Terminated |
| Z-0272-2009 | Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow…The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall… | 08/27/2008Terminated |
| Z-1965-2009 | iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model…Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was… | 08/26/2008Terminated |
| Z-2375-2008 | FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in…The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is… | 07/11/2008Terminated |