OSSIOfiber® Staple
FDA 510(k) clearance K212594 · decided 2022-01-21
Clearance details
- K-number
- K212594
- Device name
- OSSIOfiber® Staple
- Applicant
- OSSIO , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-16
- Decision date
- 2022-01-21
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- MNU
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Caesarea, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OSSIOfiber® Compression Staple (K241932) | OSSIO , Ltd. | 2024-08-28 |
| OSSIOfiber® Compression Staple (K233302) | OSSIO , Ltd. | 2023-11-16 |
| ARTHREX BIO-TRANSFIX (K011172) | Arthrex, Inc. | 2001-06-19 |
Recalls involving this device
No recalls on record reference this clearance.