MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
FDA 510(k) clearance K071934 · decided 2007-10-11
Clearance details
- K-number
- K071934
- Device name
- MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2007-07-13
- Decision date
- 2007-10-11
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JQC
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and recall (Z-1207-2009) | Biomet, Inc. | 2009-04-17 |
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|---|---|---|
| Oxford Knee System (P010014/S111) | Biomet Manufacturing Corp | 2025-08-07 |
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| Oxford® Partial Knee System (P010014/S106) | Biomet Manufacturing Corp | 2024-08-19 |
| Oxford Partial Knee (P010014/S104) | Biomet Manufacturing Corp | 2023-04-06 |