BIOPRO FEMORAL HEADS
FDA 510(k) clearance K090208 · decided 2009-05-22
Clearance details
- K-number
- K090208
- Device name
- BIOPRO FEMORAL HEADS
- Applicant
- Biopro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-28
- Decision date
- 2009-05-22
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- JDI
- Device class
- 2
- Regulation number
- 888.3350
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Port Huron, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/D recall (Z-0148-2026) | BioPro, Inc. | 2025-10-14 |
| BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation. recall (Z-0163-2012) | Biopro, Inc. | 2011-11-04 |
| BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation recall (Z-0164-2012) | Biopro, Inc. | 2011-11-04 |