CONGRUENT BONE PLATE SYSTEM— 510(k) K012655

Substantially Equivalent

Acu Med, Inc.

FDA 510(k) clearance K012655 for CONGRUENT BONE PLATE SYSTEM, Substantially Equivalent on 2001-11-07. Applicant: Acu Med, Inc..

Clearance details

Applicant: Acu Med, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2001-08-13
Decision date: 2001-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.