DePuy Corail AMT Hip Prosthesis— 510(k) K173960

Substantially Equivalent

Depuy France S.A.S.

FDA 510(k) clearance K173960 for DePuy Corail AMT Hip Prosthesis, Substantially Equivalent on 2018-09-21. Applicant: Depuy France S.A.S..

Clearance details

Applicant
Depuy France S.A.S.
Product code
Code LZO
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Saint Priest Cedex Rhone-Alpes, FR
Download summary PDFView 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, through . 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.