FDA 510(k)

REGENETEN™ Bioinductive Implant

Numéro K : K242631 · 2024-11-26

DemandeurSmith & Nephew Inc., Endoscopy Div.

Date de décision2024-11-26

Code produitOWY

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

What is the REGENETEN™ Bioinductive Implant?

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

When did REGENETEN™ Bioinductive Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for REGENETEN™ Bioinductive Implant?

The FDA 510(k) record lists Smith & Nephew Inc., Endoscopy Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGENETEN™ Bioinductive Implant?

The FDA product code for REGENETEN™ Bioinductive Implant is OWY.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : OWY)

K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.K252647Tapestry Biointegrative ImplantEmbody, Inc.K250109TYBR Collagen GelTybr Health K243843Tendon Protect (50242)Kerecis Limited K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.K220867Tapestry Biointegrative ImplantEmbody, Inc.

Source officielle

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