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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, for degenerative disc disease
510(k) Number K111099
Device Name ISSYS LP SPINAL FIXATION SYSTEM
Original Applicant
CUSTOM SPINE, INC.
1140 parsippany blvd.
suite 201
parsippany,  NJ  07054
Original 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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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