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

FDA 510(k)

DePuy Corail AMT Hip Prosthesis

K-Number: K190344 · 2019-11-01

ApplicantDepuy(Ireland)
Decision Date2019-11-01
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Corail AMT Hip Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Depuy(Ireland). It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190344. 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 2019-11-01. The listed applicant is Depuy(Ireland). The 510(k) number is K190344.

When did DePuy Corail AMT Hip Prosthesis receive FDA 510(k) clearance?

DePuy Corail AMT Hip Prosthesis received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190344.

Who is the listed applicant for DePuy Corail AMT Hip Prosthesis?

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

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 records listing Depuy(Ireland) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212683GLOBAL ICON Stemless Shoulder SystemK192855DELTA XTEND(TM) Reverse Shoulder SystemK191779Attune Revision LPS InsertsK192448Delta Xtend Revers Shoulder SystemK183077Delta Xtend Reverse Shoulder SystemK170806ATTUNE Cemented Tibial Base, Fixed Bearing

View all 9 devices →

Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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.

↑