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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K160640
Device Name PASS XS Spinal System
Applicant
Medicrea International SA
14 Porte Du Grand Lyon
Neyron,  FR 01700
Applicant Contact David Ryan
Correspondent
Medicrea International SA
14 Porte Du Grand Lyon
Neyron,  FR 01700
Correspondent Contact David Ryan
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI   OSH  
Date Received03/07/2016
Decision Date 09/23/2016
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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