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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K112648
Device Name ASFORA BULLET CAGE
Applicant
Medical Designs, LLC
1210 W. 18th St.
Suite 104
Sioux Falls,  SD  57104
Applicant Contact KRISTI VONDRA
Correspondent
Medical Designs, LLC
1210 W. 18th St.
Suite 104
Sioux Falls,  SD  57104
Correspondent Contact KRISTI VONDRA
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/12/2011
Decision Date 03/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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