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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 K120469
Device Name ERISMA-LP
Applicant
Clariance
3101 Neal Court
Cumming,  GA  30041
Applicant Contact WILLIAM JACKSON
Correspondent
Clariance
3101 Neal Court
Cumming,  GA  30041
Correspondent Contact WILLIAM JACKSON
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received02/16/2012
Decision Date 08/13/2012
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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