FDA 510(k)

Magnes-C Anterior Cervical Plate System

K-Nummer: K221053 · 2023-03-01

AntragstellerFellowship of Orthopaedic Researchers, Inc.

Entscheidungsdatum2023-03-01

ProduktcodeKWQ

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Magnes-C Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Fellowship of Orthopaedic Researchers, Inc.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K221053. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Magnes-C Anterior Cervical Plate System?

Magnes-C Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Fellowship of Orthopaedic Researchers, Inc.. The 510(k) number is K221053.

When did Magnes-C Anterior Cervical Plate System receive FDA 510(k) clearance?

Magnes-C Anterior Cervical Plate System received FDA 510(k) clearance on 2023-03-01, under 510(k) number K221053.

Who is the listed applicant for Magnes-C Anterior Cervical Plate System?

The FDA 510(k) record lists Fellowship of Orthopaedic Researchers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Magnes-C Anterior Cervical Plate System?

The FDA product code for Magnes-C Anterior Cervical Plate System is KWQ.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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

Verwandte Geräte (Code: KWQ)

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC K252776ARIES Vorderes Halsplatten-SystemZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.