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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 K931653
Device Name SPINE-TECH CERVICAL FIXATION SYSTEM
Applicant
Spinal Technologies
980 E. Hennepin Ave.
Minneapolis,  MN  55414
Applicant Contact RICHARD JANSEN
Correspondent
Spinal Technologies
980 E. Hennepin Ave.
Minneapolis,  MN  55414
Correspondent Contact RICHARD JANSEN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/05/1993
Decision Date 08/04/1994
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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