Spinal Solutions, LLC
Country not established
- Devices
- 1
- FDA recalls
- 11
At a glance
Market reach
- United States
- FDA recalls
What Spinal Solutions, LLC makes
Spinal Solutions, LLC manufactures the LANCER Pedicle Screw System, a surgical fixation device used for spinal stabilization procedures. This system includes pedicle screws and associated hardware designed for internal fixation in spinal surgeries, aiding in the alignment and support of the spine during recovery.
The LANCER Pedicle Screw System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Lancer Pedicle Screw System Ref K110633
Regimes: 510(k) Registry: 510(k)
FDA recalls
2013
- 8 Mar 2013 Z-1157-2013 Class II Terminated Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization.
- 20 Feb 2013 Z-1409-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1410-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1411-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1412-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1413-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1414-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1415-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1416-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1417-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Show all 11 recalls
2013
- 20 Feb 2013 Z-1418-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Frequently asked questions
How many devices does Spinal Solutions, LLC have in the registry?
The registry currently lists 1 device for Spinal Solutions, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spinal Solutions, LLC's devices?
Among its 1 most recently registered device, Spinal Solutions, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Spinal Solutions, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Spinal Solutions, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Spinal Solutions, LLC?
FDA recall records list 11 recalls initiated by Spinal Solutions, LLC, the most recent initiated on 8 Mar 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Spinal Solutions, LLC in the registry?
The most recently registered devices listed for Spinal Solutions, LLC include LANCER PEDICLE SCREW SYSTEM.