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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 K122497
Models 11-1106-FD1, 11-1106-FD10, 11-1106-FD11, 11-1106-FD12, 11-1106-FD13, 11-1106-FD14, 11-1106-FD15, 11-1106-FD16, 11-1106-FD17, 11-1106-FD18, 11-1106-FD19, 11-1106-FD2, 11-1106-FD20, 11-1106-FD3, 11-1106-FD4, 11-1106-FD5, 11-1106-FD6, 11-1106-FD7, 11-1106-FD8, 11-1106-FD9
Device Name ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM
Original Applicant
MEDICAL DESIGN LLC.
6709 s. minnesota ave. ste 204
sioux falls,  SD  57108 2593
Original Contact kristi vondra
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/16/2012
Decision Date 10/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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