Staple, Absorbable
FDA product code MNU · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
4510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241932 | OSSIOfiber® Compression StapleMNU · Traditional | OSSIO , Ltd. | 08/28/2024SE |
| K233302 | OSSIOfiber® Compression StapleMNU · Traditional | OSSIO , Ltd. | 11/16/2023SE |
| K212594 | OSSIOfiber® StapleMNU · Traditional | OSSIO , Ltd. | 01/21/2022SE |
| K011172 | Arthrex Bio-TransfixMNU · Traditional | Arthrex, Inc. | 06/19/2001SE |