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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
Original Applicant
SPINAL TECHNOLOGIES
980 e. hennepin ave.
minneapolis,  MN  55414
Original 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
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