K202806 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. (Guro-Gu, KR). The FDA issued a Cleared decision on June 17, 2021, 267 days after receiving the submission on September 23, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K202806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2020 |
| Decision Date | June 17, 2021 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| 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 |