FDA 510(k)

DePuy Corail AMT Hip Prosthesis

K-Number: K192946 · 2019-11-26

Decision Date2019-11-26

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DePuy Corail AMT Hip Prosthesis is a medical device manufactured by DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-11-26 under approval number K192946. 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 DePuy Corail AMT Hip Prosthesis?

DePuy Corail AMT Hip Prosthesis is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by DePuy Orthopaedics, Inc.. The 510(k) number is K192946.

When was DePuy Corail AMT Hip Prosthesis approved by the FDA?

DePuy Corail AMT Hip Prosthesis received FDA 510(k) clearance on 2019-11-26, under approval number K192946.

What company makes DePuy Corail AMT Hip Prosthesis?

DePuy Corail AMT Hip Prosthesis is manufactured by DePuy Orthopaedics, Inc..

What is the FDA product code for DePuy Corail AMT Hip Prosthesis?

The FDA product code for DePuy Corail AMT Hip Prosthesis is LZO.

Other Devices by DePuy Orthopaedics, Inc.

K170339Summit Hip System K192919Pinnacle Duofix HA Acetabular Cup Prosthesis K182301PFC SIGMA Knee System K203167DePuy Corail AMT Hip Prosthesis K202472ACTIS Duofix Hip Prosthesis K201347DePuy ATTUNE Total Knee 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.