FDA 510(k)

BellaTek Bars

Numéro K : K260940 · 2026-09-21

Date de décision2026-09-21

Code produitNHA

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

BellaTek Bars is the device name listed in this FDA 510(k) record. The listed applicant is ZimVie US Corp, LLC. It received FDA 510(k) clearance on 2026-09-21 under 510(k) number K260940. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the BellaTek Bars?

BellaTek Bars is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is ZimVie US Corp, LLC. The 510(k) number is K260940.

When did BellaTek Bars receive FDA 510(k) clearance?

BellaTek Bars received FDA 510(k) clearance on 2026-09-21, under 510(k) number K260940.

Who is the listed applicant for BellaTek Bars?

The FDA 510(k) record lists ZimVie US Corp, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BellaTek Bars?

The FDA product code for BellaTek Bars is NHA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.