BONE SCREW— 510(k) K831873

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K831873 for BONE SCREW, Substantially Equivalent on 1983-08-12. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1983-06-13
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.