ORTHOMET AUSTIN-MOORE SYSTEM— 510(k) K871656

Substantially Equivalent

Orthomet, Inc.

FDA 510(k) clearance K871656 for ORTHOMET AUSTIN-MOORE SYSTEM, Substantially Equivalent on 1987-06-09. Applicant: Orthomet, Inc..

Clearance details

Applicant: Orthomet, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1987-04-28
Decision date: 1987-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.