ACROMED WALLIE-HEINIG OSTEOTOMES
FDA 510(k) clearance K870780 · decided 1987-03-09
Clearance details
- K-number
- K870780
- Device name
- ACROMED WALLIE-HEINIG OSTEOTOMES
- Applicant
- Buckman Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-26
- Decision date
- 1987-03-09
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- HWM
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Martinez, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER (K874503) | Micro-Aire Surgical Instruments, Inc. | 1987-12-02 |
| OSTEOTOMES FOR CUTTING BONH (K771744) | Depuy, Inc. | 1977-09-28 |
Recalls involving this device
No recalls on record reference this clearance.