Ceramtec GmbH
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Ceramtec GmbH makes
Ceramtec GmbH manufactures the Transcend Hip Articulation System, a prosthetic component designed for hip replacements. This product is intended for use in total hip arthroplasty procedures, providing ceramic-on-ceramic bearing surfaces to reduce wear and friction in joint replacements.
The Transcend Hip Articulation System is classified as a Class III medical device in the US and is listed under the FDA’s Premarket Approval (PMA) pathway. The company is based in the United States.
Catalogue
Transcend Hip Articulation System Ref P010001
PMA, withdrawn PMA
FDA establishments
- Ceramtec GmbH Lauf an der Pegnitz Bavaria · DE FEI 3008886124
Frequently asked questions
How many devices does Ceramtec GmbH have in the registry?
The registry currently lists 1 device for Ceramtec GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ceramtec GmbH's devices?
Among its 1 most recently registered device, Ceramtec GmbH has devices listed in FDA PMA (1 device).
What risk classes do Ceramtec GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ceramtec GmbH's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Ceramtec GmbH in the registry?
The most recently registered devices listed for Ceramtec GmbH include TRANSCEND HIP ARTICULATION SYSTEM.
Which FDA establishments are linked to Ceramtec GmbH?
1 FDA establishment is linked to Ceramtec GmbH in the registry; they are listed on the company page.