REGENETEN Bioinductive Implant— 510(k) K242631

Substantially Equivalent

Smith & Nephew Inc., Endoscopy Div.

FDA 510(k) clearance K242631 for REGENETEN Bioinductive Implant, Substantially Equivalent on 2024-11-26. Applicant: Smith & Nephew Inc., Endoscopy Div..

Clearance details

Applicant: Smith & Nephew Inc., Endoscopy Div.
Product code: Code OWY
Advisory panel: General, Plastic Surgery
Date received: 2024-09-03
Decision date: 2024-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.