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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 K010639
Device Name CONVERGENCE CERVICAL SPINAL SYSTEM
Applicant
Spinal Innovations, LLC
7850 Stage Hills Blvd.
Suite 105
Bartlett,  TN  38133
Applicant Contact KENNETH RUSSELL
Correspondent
Spinal Innovations, LLC
7850 Stage Hills Blvd.
Suite 105
Bartlett,  TN  38133
Correspondent Contact KENNETH RUSSELL
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/05/2001
Decision Date 05/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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