ORTHOPAEDIC WIRES— 510(k) K942603

Substantially Equivalent

Acu Med, Inc.

FDA 510(k) clearance K942603 for ORTHOPAEDIC WIRES, Substantially Equivalent on 1994-11-09. Applicant: Acu Med, Inc..

Clearance details

Applicant: Acu Med, Inc.
Product code: Code LRN
Advisory panel: Orthopedic
Date received: 1994-06-01
Decision date: 1994-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

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Adverse events under product code LRN

product code LRN

Injury: 185
Total: 185

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.