MCCUTCHEN ACETABULAR CUP PROSTHESIS— 510(k) K872732

Substantially Equivalent

Dow Corning Wright

FDA 510(k) clearance K872732 for MCCUTCHEN ACETABULAR CUP PROSTHESIS, Substantially Equivalent on 1987-10-01. Applicant: Dow Corning Wright.

Clearance details

Applicant
Dow Corning Wright
Product code
Code JDI
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arlington, TN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JDI

product code JDI
Death
65
Injury
12,943
Malfunction
1,681
Total
14,689

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.