K903713 is an FDA 510(k) clearance for the OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229. This device is classified as a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I - General Controls, product code HSZ).
Submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on September 14, 1990, 31 days after receiving the submission on August 14, 1990.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K903713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 1990 |
| Decision Date | September 14, 1990 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |