Implants Intl., Ltd.
United KingdomFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Implants Intl., Ltd. makes
Implants Intl., Ltd. manufactures the RIGI-FIX Hip Stem System, a modular orthopedic implant designed for hip arthroplasty procedures. The device is intended for use in patients requiring total hip replacement, offering a fixed-bearing solution for femoral fixation.
The RIGI-FIX Hip Stem System is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Rigi-Fix Hip Stem System Ref K072101
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Implants Intl. Ltd. THORNABY-ON-TEES Stockton-on-Tees · GB FEI 1000547811
Frequently asked questions
How many devices does Implants Intl., Ltd. have in the registry?
The registry currently lists 1 device for Implants Intl., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Implants Intl., Ltd.'s devices?
Among its 1 most recently registered device, Implants Intl., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Implants Intl., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Implants Intl., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Implants Intl., Ltd. in the registry?
The most recently registered devices listed for Implants Intl., Ltd. include RIGI-FIX HIP STEM SYSTEM.
Which FDA establishments are linked to Implants Intl., Ltd.?
1 FDA establishment is linked to Implants Intl., Ltd. in the registry; they are listed on the company page.