Regeneten Bioinductive Implant— 510(k) K222501
Substantially EquivalentSmith and Nephew, Inc.
FDA 510(k) clearance K222501 for Regeneten Bioinductive Implant, Substantially Equivalent on 2023-05-11. Applicant: Smith and Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith and Nephew, Inc.
- Product code
- Code OWY
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.