K212594 is an FDA 510(k) clearance for the OSSIOfiber® Staple. This device is classified as a Staple, Absorbable (Class II - Special Controls, product code MNU).
Submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on January 21, 2022, 158 days after receiving the submission on August 16, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K212594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2021 |
| Decision Date | January 21, 2022 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNU - Staple, Absorbable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |