FDA 510(k)

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System

K-Nummer: K241034 · 2024-06-12

Entscheidungsdatum2024-06-12

ProduktcodePML

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2024-06-12 under 510(k) number K241034. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-06-12. The listed applicant is Medacta International S.A.. The 510(k) number is K241034.

When did Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System receive FDA 510(k) clearance?

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System received FDA 510(k) clearance on 2024-06-12, under 510(k) number K241034.

Who is the listed applicant for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

The FDA product code for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is PML.

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 Medacta International S.A. als Antragsteller

K260173M-Vizion Femoral Revision System Extension K253630Mpact 3D Metal Foam K254202MectaLIF 3D Metal Anterior K253940M.U.S.T. Pedicle Screw System - Extension K253328GMK 3D Metal Tibial Tray Extension K250644MSS - Monobloc stem

Alle 148 Geräte anzeigen →

Verwandte Geräte (Code: PML)

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USA K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart K222789VADER® Pedicle System, G21 CementIcotec AG K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.

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.