FDA Registration
Active
🇺🇸 United States
OVERTURE ORTHOPAEDICS
Reg #: 3027737826
·
FEI: 3027737826
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- OVERTURE ORTHOPAEDICS
- Registration Number
- 3027737826
- FEI Number
- 3027737826
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5 Peters Canyon Rd Ste 160
- City
- Irvine
- State
- CA
- ZIP
- 92606
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221292
Owner / Operator
- Firm Name
- Overture Orthopaedics
- Operator Number
- 10088496
- Address
- 5 Peters Canyon Road, Suite 160
- City
- Irvine
- State
- CA
- Postal Code
- 92606
- Country
- US
- Correspondent
- James Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2023-08-01 |
| Template | HWT | Class 1 | Orthopedic | No | 2023-10-17 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-10-16 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-10-17 |
Proprietary Names
OvertureTi
OvertureTi Knee Resurfacing System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility