Sapphire Medical Group
Country not established
- Devices
- 5
What Sapphire Medical Group makes
Sapphire Medical Group manufactures spinal implant systems for cervical spine applications, including PEEK-based interbody fusion devices and anterior cervical plating systems designed for surgical stabilization.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
A-Wedge Anterior Interbody System (A-Wedge Ais) Ref K121693
Regimes: 510(k) Registry: 510(k)Matrix HA PEEK Cervical Implant System Ref K192316
Regimes: 510(k) Registry: 510(k)SMG Anterior Cervical Plate System Ref K183073
Regimes: 510(k) Registry: 510(k)MATRIX HA PEEK Cervical IBF System Ref K232619
Regimes: 510(k) Registry: 510(k)Sapphire Cervical Implant System Ref K172674
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sapphire Medical Group have in the registry?
The registry currently lists 5 devices for Sapphire Medical Group. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sapphire Medical Group's devices?
Among its 5 most recently registered devices, Sapphire Medical Group has devices listed in FDA 510(k) (5 devices).
What risk classes do Sapphire Medical Group's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sapphire Medical Group's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sapphire Medical Group in the registry?
The most recently registered devices listed for Sapphire Medical Group include A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS), Matrix HA PEEK Cervical Implant System, SMG Anterior Cervical Plate System and MATRIX HA PEEK Cervical IBF System.