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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 Intervertebral Body
510(k) Number K091134
Device Name CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
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 Number888.3060
Classification Product Code
KWQ  
Date Received04/20/2009
Decision Date 08/17/2009
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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