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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K072866
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 Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI   NKB  
Date Received10/05/2007
Decision Date 12/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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