AESCULAP BONE MILL
FDA 510(k) clearance K860016 · decided 1986-03-19
Clearance details
- K-number
- K860016
- Device name
- AESCULAP BONE MILL
- Applicant
- Aesculap Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-03
- Decision date
- 1986-03-19
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- LYS
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Burlingame, 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 |
|---|---|---|
| TRACER BONE MILL (K883183) | De Medica Mfg., Inc. | 1988-10-12 |
| ORTHOBLEND POWERED BONE MILL (K860356) | Zimmer, Inc. | 1986-07-08 |
| OSTEOMILL BONE GRINDER (K861164) | Biodynamic Technologies, Inc. | 1986-05-02 |
Recalls involving this device
No recalls on record reference this clearance.