K924018 is an FDA 510(k) clearance for the M3 LAG SCREW FIXATION SYSTEM. This device is classified as a Screw, Fixation, Bone (Class II — Special Controls, product code HWC).
Submitted by Osteomed Corp. (Glendale, US). The FDA issued a Cleared decision on April 1, 1993, 233 days after receiving the submission on August 11, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K924018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1992 |
| Decision Date | April 01, 1993 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3040 |