HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX— 510(k) K012818

Substantially Equivalent

Triage Medical, Inc.

FDA 510(k) clearance K012818 for HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX, Substantially Equivalent on 2001-11-20. Applicant: Triage Medical, Inc..

Clearance details

Applicant: Triage Medical, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2001-08-22
Decision date: 2001-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, 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.