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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 K130958
Device Name TRUE SPINAL FIXATION SYSTEM
Applicant
Innovative Surgical Designs
2660 E. 2nd St. #10
Bloomington,  IN  47401
Applicant Contact ED MORRIS
Correspondent
Innovative Surgical Designs
2660 E. 2nd St. #10
Bloomington,  IN  47401
Correspondent Contact ED MORRIS
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received04/05/2013
Decision Date 10/17/2013
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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