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FDA-cleared K180091

UNiD Spine Analyzer

Medicrea International

Authorized purpose: Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and implant-placement measurements.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine and anatomical components used for implant placement.
Decision
2018-02-08
FDA-cleared K170172

UNiD Spine Analyzer

MEDICREA INTERNATIONAL

Authorized purpose: Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and implant-placement measurements.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine and anatomical components used for implant placement.
Decision
2017-05-24