FDA 510(k)

Adapterhülse für BIOLOX® OPTION Femurkopf, +10.5mm Kopflänge

K-Nummer: K213580 · 2021-12-03

AntragstellerTotal Joint Othopedics, Inc.

Entscheidungsdatum2021-12-03

ProduktcodeLZO

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K213580. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K213580.

When did Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length receive FDA 510(k) clearance?

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length received FDA 510(k) clearance on 2021-12-03, under 510(k) number K213580.

Who is the listed applicant for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

The FDA 510(k) record lists Total Joint Othopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

The FDA product code for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is LZO.

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

Weitere Einträge mit Total Joint Othopedics, Inc. als Antragsteller

K243991Klassic Knee System - Revision Tibial Baseplate K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post K230537Klassic Knee Revision System K191399BIOLOX CONTOURA Ceramic Femoral Head K171962Klassic HD® Hip System K161073Klassic HD Hip System

Alle 7 Geräte anzeigen →

Verwandte Geräte (Code: LZO)

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG K260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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.