Sintea Biotech, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Sintea Biotech, Inc. makes
Sintea Biotech, Inc. manufactures spinal fixation systems, including dynamic stabilization components like the DSC/ALF Spinal System, multi-axial screws for posterior lumbar stabilization, and anterior plate systems for spinal fusion. Their portfolio also includes trauma fixation solutions such as the TraumaFix System and Schanz screws, as well as hand fixation devices like the Laki Hand Fixation System. Additional products include the X-Void Spider, a device for spinal void management.
All listed devices fall under Class II regulatory classification in the US and are authorised via 510(k) clearance through the FDA. The company operates from the United States, with its products registered in the FDA’s 510(k) database.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Sintea Biotech Posterior Lumbar System With Polyaxial And Recovery Screws, Model PLS.01.T5.X Ref K043355
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
X-Void, Spider Ref K072198
Regimes: 510(k) Registry: 510(k)Laki Hand Fixation System, Model TFX.3X.06.X Ref K082679
Regimes: 510(k) Registry: 510(k)Sintea Biotech Schanz Screw, Model Tfx.ss.xx.x Ref K031154
Regimes: 510(k) Registry: 510(k)Sintea Biotech Pls Multi-Axial Screws Ref K081631
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sintea Biotech, Inc. have in the registry?
The registry currently lists 10 devices for Sintea Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sintea Biotech, Inc.'s devices?
Among its 10 most recently registered devices, Sintea Biotech, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Sintea Biotech, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Sintea Biotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sintea Biotech, Inc. in the registry?
The most recently registered devices listed for Sintea Biotech, Inc. include SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX, SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X, SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X and SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X.