K860016 is an FDA 510(k) clearance for the AESCULAP BONE MILL. This device is classified as a Bone Mill (Class I - General Controls, product code LYS).
Submitted by Aesculap Instruments Corp. (Burlingame, US). The FDA issued a Cleared decision on March 19, 1986, 75 days after receiving the submission on January 3, 1986.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K860016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1986 |
| Decision Date | March 19, 1986 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LYS — Bone Mill |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |