K203523 is an FDA 510(k) clearance for the Fixone hybrid knotless anchor. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Aju Pharm Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on December 25, 2021, 389 days after receiving the submission on December 1, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K203523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2020 |
| Decision Date | December 25, 2021 |
| Days to Decision | 389 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 |