REGENETEN Bioinductive Implant— 510(k) K242631

Name: FDA 510(k) clearance K242631
Creator: U.S. Food and Drug Administration
Published: 2024-11-26

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.. Device class: 2.

Clearance details

Applicant: Smith & Nephew Inc., Endoscopy Div.
Product code: Code OWY
Device class: Class 2
Regulation: 21 CFR 878.3300
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 ↗

Recent devices under product code OWY

view all

K251690 — Arthrex SpeedFLEX Implant2025-09-30
K252647 — Tapestry Biointegrative Implant2025-09-19
K250109 — TYBR Collagen Gel2025-06-06
K243843 — Tendon Protect (50242)2025-06-04
K222501 — Regeneten Bioinductive Implant2023-05-11

More clearances from Smith & Nephew Inc., Endoscopy Div.

view all

K111843 — ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM2011-11-14
K102544 — SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY2011-01-05
K092551 — SMITH & NEPHEW INSTRUMENT TRAYS2010-09-14
K100159 — SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR2010-04-19
K093943 — BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM2010-03-05

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