K231326 is an FDA 510(k) clearance for the Fix2Lock(Biocomposite medial, 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 May 31, 2023, 23 days after receiving the submission on May 8, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K231326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2023 |
| Decision Date | May 31, 2023 |
| Days to Decision | 23 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 |