BIOPRO 32MM BALL
FDA 510(k) clearance K872856 · decided 1987-08-17
Clearance details
- K-number
- K872856
- Device name
- BIOPRO 32MM BALL
- Applicant
- Biopro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-21
- Decision date
- 1987-08-17
- Days to decision
- 27 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 Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL recall (Z-0153-2026) | BioPro, Inc. | 2025-10-14 |