Aesculap Implants Systems, LLC
United StatesFDA applicant, unverified
- Devices
- 4
What Aesculap Implants Systems, LLC makes
Aesculap Implants Systems, LLC manufactures orthopedic implant systems, including modular hip replacements under the CoreHip® brand, knee arthroplasty systems (VEGA and Columbus Total Knee), and next-generation surgical instrumentation (activL®). These products are designed for primary and revision total joint arthroplasty procedures.
The company’s portfolio is regulated as Class II medical devices in the US, with devices authorised via the FDA’s 510(k) pathway. The products are listed under the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
CoreHip® System Ref K172235
Regimes: 510(k) Registry: 510(k)Modulift Vertebral Body Replacement (VBR) System Ref K172032
Regimes: 510(k) Registry: 510(k)activL® Next Generation Instrumentation Ref K231769
Regimes: 510(k) Registry: 510(k)VEGA Knee System, Columbus Total Knee System Ref K143443
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aesculap Implants Systems, LLC have in the registry?
The registry currently lists 4 devices for Aesculap Implants Systems, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aesculap Implants Systems, LLC's devices?
Among its 4 most recently registered devices, Aesculap Implants Systems, LLC has devices listed in FDA 510(k) (4 devices).
What risk classes do Aesculap Implants Systems, LLC's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Aesculap Implants Systems, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aesculap Implants Systems, LLC in the registry?
The most recently registered devices listed for Aesculap Implants Systems, LLC include CoreHip® System, Modulift Vertebral Body Replacement (VBR) System, activL® Next Generation Instrumentation and VEGA Knee System, Columbus Total Knee System.