CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM— 510(k) K141949

Substantially Equivalent

Aap Implantate AG

FDA 510(k) clearance K141949 for CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM, Substantially Equivalent on 2014-09-12. Applicant: Aap Implantate AG.

Clearance details

Applicant: Aap Implantate AG
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2014-07-18
Decision date: 2014-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

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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.