SpineSmith Holdings, LLC
United Statesfrom the FDA registration address FDA establishment FEI 3006404071
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 1
What SpineSmith Holdings, LLC makes
SpineSmith Holdings, LLC manufactures spinal fixation systems, spinal fusion platforms, and aspiration needles for medical use.
The company's devices are classified as Class II and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
IN:C2 Spinal Fixation Systme Ref K141537
Regimes: 510(k) Registry: 510(k)CorticaLINK Spinal Fusion Platform Ref K193465
Regimes: 510(k) Registry: 510(k)Celling Aspiration Needle Ref K180807
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3006404071
- Address
- 4719 South Congress Ave., AUSTIN, TX, 78745
FDA recalls
FDA recall records list 1 recall initiated by SpineSmith Holdings, LLC, initiated on 2013-07-31. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 31 Jul 2013 Z-2258-2013 Class II Terminated The product has the potential to be laser marked as a Medium when it actually is a Small.
Frequently asked questions
How many devices does SpineSmith Holdings, LLC have in the registry?
The registry currently lists 3 devices for SpineSmith Holdings, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list SpineSmith Holdings, LLC's devices?
Among its 3 most recently registered devices, SpineSmith Holdings, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do SpineSmith Holdings, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for SpineSmith Holdings, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for SpineSmith Holdings, LLC?
FDA recall records list 1 recall initiated by SpineSmith Holdings, LLC, the most recent initiated on 31 Jul 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 SpineSmith Holdings, LLC in the registry?
The most recently registered devices listed for SpineSmith Holdings, LLC include IN:C2 SPINAL FIXATION SYSTME, CorticaLINK Spinal Fusion Platform and Celling Aspiration Needle.