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FDA 510(k)

M-Vizion Femoral Revision System Extension

K-Number: K191816 · 2020-04-29

ApplicantMedacta International S.A.
Decision Date2020-04-29
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M-Vizion Femoral Revision System Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-04-29 under approval number K191816. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-Vizion Femoral Revision System Extension?

M-Vizion Femoral Revision System Extension is a medical device that received FDA 510(k) clearance on 2020-04-29. It is manufactured by Medacta International S.A.. The 510(k) number is K191816.

When was M-Vizion Femoral Revision System Extension approved by the FDA?

M-Vizion Femoral Revision System Extension received FDA 510(k) clearance on 2020-04-29, under approval number K191816.

What company makes M-Vizion Femoral Revision System Extension?

M-Vizion Femoral Revision System Extension is manufactured by Medacta International S.A..

What is the FDA product code for M-Vizion Femoral Revision System Extension?

The FDA product code for M-Vizion Femoral Revision System Extension is LZO.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT06657183 ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07571408 Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease NOT_YET_RECRUITING NCT04090359 Dual Mobility Acetabular Cups in Revision TJA RECRUITING

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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