K243467 is an FDA 510(k) clearance for the Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching). This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Osteonic Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 3, 2024, 25 days after receiving the submission on November 8, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K243467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | December 03, 2024 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAI — Fastener, Fixation, Biodegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |