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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 K140738
Device Name PASS LP SPINAL SYSTEM
Applicant
Medicrea International
14 Porte Du Grand Lyon
Neyron,  FR 01700
Applicant Contact David Ryan
Correspondent
Medicrea International
14 Porte Du Grand Lyon
Neyron,  FR 01700
Correspondent Contact David Ryan
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH   OSH  
Date Received03/25/2014
Decision Date 11/04/2014
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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