K861164 is an FDA 510(k) clearance for the OSTEOMILL BONE GRINDER. This device is classified as a Bone Mill (Class I - General Controls, product code LYS).
Submitted by Biodynamic Technologies, Inc. (Arlington, US). The FDA issued a Cleared decision on May 2, 1986, 35 days after receiving the submission on March 28, 1986.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K861164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1986 |
| Decision Date | May 02, 1986 |
| Days to Decision | 35 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 |