Regeneten Bioinductive Implant— 510(k) K222501

Substantially Equivalent

Smith and Nephew, Inc.

FDA 510(k) clearance K222501 for Regeneten Bioinductive Implant, Substantially Equivalent on 2023-05-11. Applicant: Smith and Nephew, Inc..

Clearance details

Applicant: Smith and Nephew, Inc.
Product code: Code OWY
Advisory panel: General, Plastic Surgery
Date received: 2022-08-18
Decision date: 2023-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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