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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K141187
Device Name IMPIX ALIF S/A
Applicant
MEDICREA INTERNATIONAL S.A.
14 PORTE DU GRAND LYON
NEYRON,  FR 01700
Applicant Contact DAVID RYAN
Correspondent
MEDICREA INTERNATIONAL S.A.
14 PORTE DU GRAND LYON
NEYRON,  FR 01700
Correspondent Contact DAVID RYAN
Regulation Number888.3080
Classification Product Code
OVD  
Date Received05/08/2014
Decision Date 01/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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