Sintea Plastek, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Sintea Plastek, LLC makes
Sintea Plastek, LLC manufactures multi-axial screws for orthopedic fixation, including the SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS, designed for spinal stabilization. The company also produces the DSC/ALF SPINAL SYSTEM, a spinal fixation device used in surgical procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance in the United States. The company is headquartered in the US.
Catalogue
Sintea Plustek Pls Multi-Axial Screws Ref K112611
Regimes: 510(k) Registry: 510(k)Dsc/Alf Spinal System Ref K101886
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sintea Plastek, LLC have in the registry?
The registry currently lists 2 devices for Sintea Plastek, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sintea Plastek, LLC's devices?
Among its 2 most recently registered devices, Sintea Plastek, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Sintea Plastek, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sintea Plastek, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sintea Plastek, LLC in the registry?
The most recently registered devices listed for Sintea Plastek, LLC include SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS and DSC/ALF SPINAL SYSTEM.