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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 K101151
Device Name REGENT ANTERIOR CERVICAL PLATE
Applicant
Custom Spine
1140 Parsippany Blvd., Suite 20
Parsippany,  NJ  07054
Applicant Contact SAAD ATTIYAH
Correspondent
Custom Spine
1140 Parsippany Blvd., Suite 20
Parsippany,  NJ  07054
Correspondent Contact SAAD ATTIYAH
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/23/2010
Decision Date 05/19/2010
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
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