THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA— 510(k) K133875

Substantially Equivalent

Ortho Kinematics, Inc.

FDA 510(k) clearance K133875 for THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA, Substantially Equivalent on 2014-01-17. Applicant: Ortho Kinematics, Inc..

Clearance details

Applicant: Ortho Kinematics, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-12-20
Decision date: 2014-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.