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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
Applicant
Medicrea International, Inc.
5389 Route De Strasbourg - Vancia
Rilleux La Pape,  FR 69140
Applicant Contact David Ryan
Correspondent
Sterling Medical Devices
250 Moonachie Rd.
Moonachie,  NJ  07074
Correspondent Contact Teal Bjoraker
Regulation Number892.2050
Classification Product Code
LLZ  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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