AMSET(TM) BONE SCREW— 510(k) K911768

Substantially Equivalent

Advanced Med/Surg, Inc.

FDA 510(k) clearance K911768 for AMSET(TM) BONE SCREW, Substantially Equivalent on 1991-10-04. Applicant: Advanced Med/Surg, Inc..

Clearance details

Applicant: Advanced Med/Surg, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1991-04-19
Decision date: 1991-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, 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.