K202663 is an FDA 510(k) clearance for the Suture Wing. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Osteonic Co., Ltd. (Guro-Gu, KR). The FDA issued a Cleared decision on June 7, 2021, 266 days after receiving the submission on September 14, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K202663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2020 |
| Decision Date | June 07, 2021 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBI — Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |