Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DM Converter - TiN coated

K-Number: K211891 · 2022-07-22

ApplicantMedacta International S.A.
Decision Date2022-07-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DM Converter - TiN coated is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2022-07-22 under approval number K211891. 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 DM Converter - TiN coated?

DM Converter - TiN coated is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Medacta International S.A.. The 510(k) number is K211891.

When was DM Converter - TiN coated approved by the FDA?

DM Converter - TiN coated received FDA 510(k) clearance on 2022-07-22, under approval number K211891.

What company makes DM Converter - TiN coated?

DM Converter - TiN coated is manufactured by Medacta International S.A..

What is the FDA product code for DM Converter - TiN coated?

The FDA product code for DM Converter - TiN coated 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.

↑