FDA 510(k)

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems

Numéro K : K160879 · 2016-12-20

Date de décision2016-12-20

Code produitPML

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medos International Sàrl. It received FDA 510(k) clearance on 2016-12-20 under 510(k) number K160879. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems?

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is a medical device that received FDA 510(k) clearance on 2016-12-20. The listed applicant is Medos International Sàrl. The 510(k) number is K160879.

When did CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems receive FDA 510(k) clearance?

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems received FDA 510(k) clearance on 2016-12-20, under 510(k) number K160879.

Who is the listed applicant for CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems?

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

What is the FDA product code for CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems?

The FDA product code for CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is PML.

Essais cliniques associés

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Dispositifs connexes (Code : PML)

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.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

Source officielle

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