FDA 510(k)

REGENETEN Bioinductive Implant

K-Number: K242631 · 2024-11-26

ApplicantSmith & Nephew Inc., Endoscopy Div.

Decision Date2024-11-26

Product CodeOWY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

REGENETEN Bioinductive Implant is a medical device manufactured by Smith & Nephew Inc., Endoscopy Div.. It received FDA 510(k) clearance on 2024-11-26 under approval number K242631. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGENETEN Bioinductive Implant?

REGENETEN Bioinductive Implant is a medical device that received FDA 510(k) clearance on 2024-11-26. It is manufactured by Smith & Nephew Inc., Endoscopy Div.. The 510(k) number is K242631.

When was REGENETEN Bioinductive Implant approved by the FDA?

REGENETEN Bioinductive Implant received FDA 510(k) clearance on 2024-11-26, under approval number K242631.

What company makes REGENETEN Bioinductive Implant?

REGENETEN Bioinductive Implant is manufactured by Smith & Nephew Inc., Endoscopy Div..

What is the FDA product code for REGENETEN Bioinductive Implant?

The FDA product code for REGENETEN Bioinductive Implant is OWY.

Related Devices (Code: OWY)

K151083BioBridge Collagen MatrixFibralign Corporation K201572TAPESTRY Biointegrative ImplantEmbody, Inc. K212306Tapestry Biointegrative ImplantEmbody, Inc. K220867Tapestry Biointegrative ImplantEmbody, Inc. K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc. K251690Arthrex SpeedFLEX ImplantArthrex, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.