ORTHOTRAC COAXIAL LASER— 510(k) K933431

Substantially Equivalent

Trac Medical, Inc.

FDA 510(k) clearance K933431 for ORTHOTRAC COAXIAL LASER, Substantially Equivalent on 1993-10-05. Applicant: Trac Medical, Inc..

Clearance details

Applicant: Trac Medical, Inc.
Product code: Code OXO
Advisory panel: Radiology
Date received: 1993-07-14
Decision date: 1993-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raliegh, NC, US

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.