BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS— 510(k) K080088

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K080088 for BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS, Substantially Equivalent on 2008-06-11. Applicant: Biomet Manufacturing, Inc..

Clearance details

Applicant: Biomet Manufacturing, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2008-01-14
Decision date: 2008-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.