K210122 is an FDA 510(k) clearance for the Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw). 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 August 27, 2021, 220 days after receiving the submission on January 19, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K210122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2021 |
| Decision Date | August 27, 2021 |
| Days to Decision | 220 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 |