UNIVERSAL COMPRESSION SCREW— 510(k) K904809

Substantially Equivalent for Some Indications

Howmedica Corp.

FDA 510(k) clearance K904809 for UNIVERSAL COMPRESSION SCREW, Substantially Equivalent for Some Indications on 1991-06-28. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1990-10-24
Decision date: 1991-06-28
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rutherford, NJ, US

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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.