FDA 510(k)

MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments

Numéro K : K173472 · 2018-04-19

Date de décision2018-04-19

Code produitPQC

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments 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 2018-04-19 under 510(k) number K173472. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments?

MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Medacta International S.A.. The 510(k) number is K173472.

When did MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments receive FDA 510(k) clearance?

MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments received FDA 510(k) clearance on 2018-04-19, under 510(k) number K173472.

Who is the listed applicant for MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments?

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 MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments?

The FDA product code for MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments is PQC.

Essais cliniques associés

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Autres dossiers indiquant Medacta International S.A. en tant que demandeur

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

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Dispositifs connexes (Code : PQC)

K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical K231483MySpine Unilateral GuidesMedacta International S.A.K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)Medacta International S.A.K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.

Source officielle

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