K243760 is an FDA 510(k) clearance for the OSSIOfiber® Suture Anchor 2.5-3.5 mm. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on April 3, 2025, 118 days after receiving the submission on December 6, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K243760 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2024 |
| Decision Date | April 03, 2025 |
| Days to Decision | 118 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 |