ORTHOPLAN— 510(k) K974406

Substantially Equivalent

Ortho-Graphics, Inc.

FDA 510(k) clearance K974406 for ORTHOPLAN, Substantially Equivalent on 1998-02-18. Applicant: Ortho-Graphics, Inc..

Clearance details

Applicant: Ortho-Graphics, Inc.
Product code: Code HWT
Advisory panel: Orthopedic
Date received: 1997-11-21
Decision date: 1998-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saltlake, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWT

product code HWT

Injury: 218
Malfunction: 12,907
Total: 13,125

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.