REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW— 510(k) K892214

Substantially Equivalent

Ace Medical Co.

FDA 510(k) clearance K892214 for REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW, Substantially Equivalent on 1989-06-22. Applicant: Ace Medical Co..

Clearance details

Applicant: Ace Medical Co.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1989-04-03
Decision date: 1989-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, CA, 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.