Data / Medical devices / United Kingdom / Innovate Orthopaedics Ltd.
Innovate Orthopaedics Ltd.: FDA-registered device maker in Huddersfield Kirklees, United Kingdom, 1 510(k) clearance
Innovate Orthopaedics Ltd. is registered with the FDA (registration 3022520753) in Huddersfield Kirklees, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 30, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022520753
- Address
- Innovate Orthopaedics Ltd The Globe, Bridge Street, Slaithwaite, Huddersfield Kirklees, United Kingdom, HD7 5JN
- Owner or operator
- Innovate Orthopaedics Ltd. (10084498)
- Roles
- Manufacturer
- First device listed
- March 17, 2022
- Registered through
- 2026
- Brand names listed
- Quick-Start
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 30, 2021 | K212547 | Quick-Start Screws | HWC | Substantially Equivalent | Innovate Orthopaedics Limited | accessdata.fda.gov |
Compare with other makers
Updated December 30, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.