ACUTRAK PLUS FIXATION SYSTEM— 510(k) K944330

Substantially Equivalent for Some Indications

Acu Med, Inc.

FDA 510(k) clearance K944330 for ACUTRAK PLUS FIXATION SYSTEM, Substantially Equivalent for Some Indications on 1995-05-05. Applicant: Acu Med, Inc..

Clearance details

Applicant: Acu Med, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1994-09-06
Decision date: 1995-05-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Beaverton, OR, 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.