BIOMET CABLE SYSTEM— 510(k) K071271

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K071271 for BIOMET CABLE SYSTEM, Substantially Equivalent on 2007-10-23. Applicant: Biomet Manufacturing, Inc..

Clearance details

Applicant
Biomet Manufacturing, Inc.
Product code
Code JDQ
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JDQ

product code JDQ
Death
9
Injury
330
Total
339

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.