Theken Surgical, LLC
United StatesFDA applicant, unverified
- Devices
- 9
What Theken Surgical, LLC makes
Theken Surgical, LLC manufactures orthopedic devices for spinal and vertebral applications, including cement restrictors for controlled bone cement delivery, a vertebral body replacement system for spinal fusion, and fixation systems for thoraco-lumbar stabilization. Their portfolio also includes an anterior column fixation system and a vertebral body replacement system with expandable cages.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Dogbone Acfs Ref K994383
Regimes: 510(k) Registry: 510(k)Theken Small Cement Restrictor Ref K012278
Regimes: 510(k) Registry: 510(k)Theken Reveal Vbr System Ref K050058
Regimes: 510(k) Registry: 510(k)Tether Acfs Ref K010466
Regimes: 510(k) Registry: 510(k)Bodyform Thoraco-Lumbar Fixation System Ref K983622
Regimes: 510(k) Registry: 510(k)Nonlinear Taper Lag Screw Ref K994382
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Coral Spinal System Ref K041592
Regimes: 510(k) Registry: 510(k)Theken Large Cement Restrictor Ref K012462
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Theken Surgical, Llc have in the registry?
The registry currently lists 9 devices for Theken Surgical, Llc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Theken Surgical, Llc's devices?
Among its 9 most recently registered devices, Theken Surgical, Llc has devices listed in FDA 510(k) (9 devices).
What risk classes do Theken Surgical, Llc's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Theken Surgical, Llc's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Theken Surgical, Llc in the registry?
The most recently registered devices listed for Theken Surgical, Llc include DOGBONE ACFS, THEKEN SMALL CEMENT RESTRICTOR, THEKEN REVEAL VBR SYSTEM and TETHER ACFS.