Centerpulse Orthopedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Centerpulse Orthopedics, Inc. makes
Centerpulse Orthopedics, Inc. manufactures orthopedic devices including tibial spacers, femoral stems, acetabular inserts, knee systems, reinforcement cups, bipolar implants, acetabular liners, and cone prostheses.
The company's portfolio includes Class II and Class III medical devices listed in the FDA 510(k) registry, and is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Natural-Knee Ii Unicompartmental Knee System Ref K033810
Regimes: 510(k) Registry: 510(k)Alloclassic Zweymueller Sl/Sll Femoral Stem Ref K030373
Regimes: 510(k) Registry: 510(k)Converge Reti-Lock Multi-Hole Reinforcement Cup Ref K032348
Regimes: 510(k) Registry: 510(k)Durasul Bipolar Ref K040947
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Epsilon Durasul Constrained Acetabular Liner Ref K030923
Regimes: 510(k) Registry: 510(k)Wagner Cone Prosthesis Ref K032380
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Centerpulse Orthopedics, Inc., initiated on 2003-09-30. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 30 Sep 2003 Z-0809-04 Unclassified (pre-2012) Terminated Compalints of acetabular shell disassociating with the bone.
Frequently asked questions
How many devices does Centerpulse Orthopedics, Inc. have in the registry?
The registry currently lists 10 devices for Centerpulse Orthopedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Centerpulse Orthopedics, Inc.'s devices?
Among its 10 most recently registered devices, Centerpulse Orthopedics, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Centerpulse Orthopedics, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Centerpulse Orthopedics, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Centerpulse Orthopedics, Inc.?
FDA recall records list 1 recall initiated by Centerpulse Orthopedics, Inc., the most recent initiated on 30 Sep 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Centerpulse Orthopedics, Inc. in the registry?
The most recently registered devices listed for Centerpulse Orthopedics, Inc. include TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE, MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM, ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED and NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM.