FDA 510(k)

FusionFrame Ring Lock System

Numéro K : K200343 · 2020-09-14

Date de décision2020-09-14

Code produitKTT

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

FusionFrame Ring Lock System is the device name listed in this FDA 510(k) record. The listed applicant is Glw Medical Innovation. It received FDA 510(k) clearance on 2020-09-14 under 510(k) number K200343. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the FusionFrame Ring Lock System?

FusionFrame Ring Lock System is a medical device that received FDA 510(k) clearance on 2020-09-14. The listed applicant is Glw Medical Innovation. The 510(k) number is K200343.

When did FusionFrame Ring Lock System receive FDA 510(k) clearance?

FusionFrame Ring Lock System received FDA 510(k) clearance on 2020-09-14, under 510(k) number K200343.

Who is the listed applicant for FusionFrame Ring Lock System?

The FDA 510(k) record lists Glw Medical Innovation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FusionFrame Ring Lock System?

The FDA product code for FusionFrame Ring Lock System is KTT.

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 : KTT)

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC K260900DYNEX® External Fixation SystemsVilex, LLC K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean Global K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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.