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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 K022997
Device Name SPECTRUM CERVICAL SPINAL SYSTEM
Applicant
Spinal Innovations, LLC
7850 Stage Hills Blvd.
Suite 105
Bartlett,  TN  38133 -4029
Applicant Contact JOSEPH S CLIFT
Correspondent
Spinal Innovations, LLC
7850 Stage Hills Blvd.
Suite 105
Bartlett,  TN  38133 -4029
Correspondent Contact JOSEPH S CLIFT
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/09/2002
Decision Date 12/06/2002
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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