Regeneten Bioinductive Implant
FDA 510(k) clearance K222501 · decided 2023-05-11
Clearance details
- K-number
- K222501
- Device name
- Regeneten Bioinductive Implant
- Applicant
- Smith and Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-18
- Decision date
- 2023-05-11
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- OWY
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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| BioBridge Collagen Matrix (K151083) | Fibralign Corporation | 2016-01-08 |
| COLLAGEN TENDON SHEET-DDI (CTS-DDI) (K140300) | Rotation Medical, Inc. | 2014-03-26 |
| MESO TENDON MATRIX (K133169) | Kensey Nash Corporation Dba Dsm Biomedical | 2013-12-20 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Agili-C (P210034) | Smith and Nephew, Inc. | 2022-03-29 |