ACUMED BONE GRAFT SYSTEM
FDA 510(k) clearance K960711 · decided 1996-05-07
Clearance details
- K-number
- K960711
- Device name
- ACUMED BONE GRAFT SYSTEM
- Applicant
- Acu Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-02-21
- Decision date
- 1996-05-07
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- KIJ
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Beaverton, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 6mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsbo recall (Z-2118-2008) | Acumed LLC | 2008-09-20 |
| 10mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsb recall (Z-2119-2008) | Acumed LLC | 2008-09-20 |