K821695 is an FDA 510(k) clearance for the MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER. This device is classified as a Burr, Orthopedic (Class I - General Controls, product code HTT).
Submitted by Micro-Aire Surgical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982, 42 days after receiving the submission on June 8, 1982.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K821695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1982 |
| Decision Date | July 20, 1982 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HTT — Burr, Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |