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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
Device Name ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM
Applicant
MEDICAL DESIGN LLC.
6709 S. MINNESOTA AVE. STE 204
SIOUX FALLS,  SD  57108 -2593
Applicant Contact KRISTI VONDRA
Correspondent
MEDICAL DESIGN LLC.
6709 S. MINNESOTA AVE. STE 204
SIOUX FALLS,  SD  57108 -2593
Correspondent Contact KRISTI VONDRA
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/16/2012
Decision Date 10/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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