Sulzermedica
Country not established
- Devices
- 6
What Sulzermedica makes
Sulzermedica manufactures vascular prostheses, including expanded polytetrafluoroethylene (EPTFE) grafts like the Vascutek EPTFE Vascular Prosthesis and GelSoft Vascular Prosthesis, as well as PTFE-based vascular sealants such as the SealPTFE Vascular Prosthesis. The company also produces orthopedic implants, such as the Metasul acetabular insert for hip replacements and modular femoral components for severe bone loss in trauma cases. Additionally, it supplies knee implants, including the Natural-Knee with CSTI technology.
The company’s products are regulated under FDA pathways, with vascular prostheses and some orthopedic implants classified as Class II devices, while others, including certain hip and knee implants, fall under Class III. These devices are authorised via FDA 510(k) clearances and Premarket Approval Applications (PMAs). Sulzermedica is based in the United States.
Catalogue
Sulzer Vascutek Eptfe Vascular Prosthesis Ref K992832
Regimes: 510(k) Registry: 510(k)Apr Metasul Acetabular Insert Ref K993569
Regimes: 510(k) Registry: 510(k)Sulzer Vascutek Gelsoft Vascular Prosthesis Ref K990503
Regimes: 510(k) Registry: 510(k)Modified To Modular Fr Severe Bone Loss Trauma Ref K002324
Regimes: 510(k) Registry: 510(k)Sulzer Vascutek Sealptfe Vascular Prosthesis Ref K993667
Regimes: 510(k) Registry: 510(k)Natural-Knee(R) With Csti(Tm) Ref P940002
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Sulzermedica have in the registry?
The registry currently lists 6 devices for Sulzermedica. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sulzermedica's devices?
Among its 6 most recently registered devices, Sulzermedica has devices listed in FDA 510(k) (5 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sulzermedica's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sulzermedica's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Sulzermedica in the registry?
The most recently registered devices listed for Sulzermedica include SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS, APR METASUL ACETABULAR INSERT, SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS and MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA.