OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
FDA 510(k) clearance K091321 · decided 2009-09-11
Clearance details
- K-number
- K091321
- Device name
- OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
- Applicant
- Bacterin International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-05
- Decision date
- 2009-09-11
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Belgrade, MT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OsteoSelect DBM Putty Product Usage: Orthopedic bone filler recall (Z-1138-2013) | Bacterin International, Inc. | 2013-04-17 |
| Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B recall (Z-0800-2013) | Bacterin International, Inc. | 2013-02-11 |