MBCP+
FDA 510(k) clearance K063527 · decided 2007-07-30
Clearance details
- K-number
- K063527
- Device name
- MBCP+
- Applicant
- Biomatlante
- Decision
- Substantially Equivalent
- Date received
- 2006-11-22
- Decision date
- 2007-07-30
- Days to decision
- 250 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Vigneux De Bretagne, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patie recall (Z-1677-2011) | Biostructures, LLC | 2011-03-16 |