K914998 is an FDA 510(k) clearance for the MICROAIRE(R) FACIAL BONE PLATING SYSTEM. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Micro Surgical Instruments Corp. (Valencia, US). The FDA issued a Cleared decision on June 2, 1992, 208 days after receiving the submission on November 7, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K914998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1991 |
| Decision Date | June 02, 1992 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |