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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K121323
Device Name MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
Applicant
Medicrea International
14 Porte Du Grand Lyon
Neyron,  FR 01700
Applicant Contact LAURE AVIRON-VIOLET
Correspondent
Medicrea International
14 Porte Du Grand Lyon
Neyron,  FR 01700
Correspondent Contact LAURE AVIRON-VIOLET
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/02/2012
Decision Date 07/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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