MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM— 510(k) K020446

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K020446 for MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM, Substantially Equivalent on 2002-03-13. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2002-02-11
Decision date: 2002-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, 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.