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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K150049
Device Name PASS LP Spinal System
Applicant
Medicrea International
14 Porte Du Grand Lyon
Neyron,  FR 01700
Applicant Contact Audrey Vion
Correspondent
Medicrea International
14 Porte Du Grand Lyon
Neyron,  FR 01700
Correspondent Contact Audrey Vion
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH   OSH  
Date Received01/12/2015
Decision Date 02/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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