FDA 510(k)

M-Vizion Monobloc

K-Number: K212327 · 2022-05-24

Decision Date2022-05-24

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

M-Vizion Monobloc is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2022-05-24 under approval number K212327. 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 Monobloc?

M-Vizion Monobloc is a medical device that received FDA 510(k) clearance on 2022-05-24. It is manufactured by Medacta International S.A.. The 510(k) number is K212327.

When was M-Vizion Monobloc approved by the FDA?

M-Vizion Monobloc received FDA 510(k) clearance on 2022-05-24, under approval number K212327.

What company makes M-Vizion Monobloc?

M-Vizion Monobloc is manufactured by Medacta International S.A..

What is the FDA product code for M-Vizion Monobloc?

The FDA product code for M-Vizion Monobloc is LZO.

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

View all 146 devices →

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.