GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
FDA 510(k) clearance K082615 · decided 2008-10-16
Clearance details
- K-number
- K082615
- Device name
- GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
- Applicant
- Osteotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-09
- Decision date
- 2008-10-16
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Eatontown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized B recall (Z-2524-2023) | Medtronic Sofamor Danek USA Inc | 2023-09-08 |