DePuy Corail AMT Hip Prosthesis— 510(k) K190344

Substantially Equivalent

Depuy(Ireland)

FDA 510(k) clearance K190344 for DePuy Corail AMT Hip Prosthesis, Substantially Equivalent on 2019-11-01. Applicant: Depuy(Ireland).

Clearance details

Applicant: Depuy(Ireland)
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2019-02-14
Decision date: 2019-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cork, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.