Data / Medical devices / United States / Overture Orthopaedics
Overture Orthopaedics: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances
Overture Orthopaedics is registered with the FDA (registration 3027737826) in Irvine, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 7, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027737826
- Address
- 2 Corporate Park Ste 106, Irvine, CA, United States, 92606
- Owner or operator
- Overture Orthopaedics (10088496)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 1, 2023
- Registered through
- 2027
- Brand names listed
- OvertureTi, OvertureTi Knee Resurfacing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 7, 2024 | K242746 | OvertureTi Knee Resurfacing SystemTM | HSX | Substantially Equivalent | Overture Orthopaedics | accessdata.fda.gov |
| March 10, 2023 | K221292 | Uni Knee Resurfacing System | HSX | Substantially Equivalent | Overture Resurfacing, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- All makers of Tray, Surgical, Instrument
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Template
Updated October 7, 2024. 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.