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FDA 510(k)

Regeneten Bioinductive Implant

K-Number: K222501 · 2023-05-11

ApplicantSmith and Nephew, Inc.
Decision Date2023-05-11
Product CodeOWY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Regeneten Bioinductive Implant is a medical device manufactured by Smith and Nephew, Inc.. It received FDA 510(k) clearance on 2023-05-11 under approval number K222501. 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 2023-05-11. It is manufactured by Smith and Nephew, Inc.. The 510(k) number is K222501.

When was Regeneten Bioinductive Implant approved by the FDA?

Regeneten Bioinductive Implant received FDA 510(k) clearance on 2023-05-11, under approval number K222501.

What company makes Regeneten Bioinductive Implant?

Regeneten Bioinductive Implant is manufactured by Smith and Nephew, Inc..

What is the FDA product code for Regeneten Bioinductive Implant?

The FDA product code for Regeneten Bioinductive Implant is OWY.

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Related Devices (Code: OWY)

K151083BioBridge Collagen MatrixFibralign Corporation K201572TAPESTRY Biointegrative ImplantEmbody, Inc. K212306Tapestry Biointegrative ImplantEmbody, Inc. K220867Tapestry Biointegrative ImplantEmbody, Inc. K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div. 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.

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