ASFORA BULLET CAGE


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

Correspodent Contact kristi vondra
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 09/12/2011
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