MINI CANNULATED HEADED AND HEADLESS SCREW SET— 510(k) K120493

Substantially Equivalent

Instratek, Inc.

FDA 510(k) clearance K120493 for MINI CANNULATED HEADED AND HEADLESS SCREW SET, Substantially Equivalent on 2012-05-17. Applicant: Instratek, Inc..

Clearance details

Applicant: Instratek, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2012-02-17
Decision date: 2012-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.