ALLOFUSE GEL AND PUTTY
FDA 510(k) clearance K071849 · decided 2008-12-04
Clearance details
- K-number
- K071849
- Device name
- ALLOFUSE GEL AND PUTTY
- Applicant
- Allosource, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-05
- Decision date
- 2008-12-04
- Days to decision
- 518 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Centennial, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applicat recall (Z-1562-2014) | AlloSource, Inc. | 2014-05-06 |