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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K153169
Device Name PASS OCT Patient Specific Rods
Applicant
Medicrea International
14 Porte Du Grand Lyon
Neyron,  FR 01700
Applicant Contact Davis Ryan
Correspondent
Medicrea International
14 Porte Du Grand Lyon
Neyron,  FR 01700
Correspondent Contact David Ryan
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received11/02/2015
Decision Date 01/29/2016
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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