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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K212005
Device Name UNiD Spine Analyzer
MEDICREA International, Inc.
5389 Route de Strasbourg - Vancia
Rilleux La Pape,  FR 69140
Applicant Contact David Ryan
Sterling Medical Devices
250 Moonachie Road
Moonachie,  NJ  07074
Correspondent Contact Teal Bjoraker
Regulation Number892.2050
Classification Product Code
Date Received06/28/2021
Decision Date 01/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No