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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 K111099
Device Name ISSYS LP SPINAL FIXATION SYSTEM
Applicant
Custom Spine, Inc.
1140 Parsippany Blvd.
Suite 201
Parsippany,  NJ  07054
Applicant Contact SAAD ATTIYAH
Correspondent
Custom Spine, Inc.
1140 Parsippany Blvd.
Suite 201
Parsippany,  NJ  07054
Correspondent Contact SAAD ATTIYAH
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received04/20/2011
Decision Date 05/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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