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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 K153326
Device Name Erisma-LP Spinal Fixation System
Applicant
CLARIANCE, SAS
18, rue Robespierre
BEAURAINS,  FR 62217
Applicant Contact PASCAL ROKEGEM
Correspondent
HOGAN LOVELLS US LLP
1835 MARKET STREET
29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received11/19/2015
Decision Date 03/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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