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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 K070281
Device Name ISSYS LP SPINAL FIXATION SYSTEM
Applicant
Custom Spine, Inc.
13540 Guild Ave.
Apple Valley,  MN  55124
Applicant Contact RICHARD JANSEN
Correspondent
Custom Spine, Inc.
13540 Guild Ave.
Apple Valley,  MN  55124
Correspondent Contact RICHARD JANSEN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received01/29/2007
Decision Date 06/11/2007
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
Recalls CDRH Recalls
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