FRONTIER SADL INTERBODY FUSION DEVICE


Device Classification Name

intervertebral fusion device with integrated fixation, lumbar

510(k) Number K112700
Device Name FRONTIER SADL INTERBODY FUSION DEVICE
Applicant
FRONTIER MEDICAL DEVICES, INC.
13540 guild avenue
apple valley, 
MN 
55124

Applicant Contact rich jansen
Correspondent
FRONTIER MEDICAL DEVICES, INC.
13540 guild avenue
apple valley, 
MN 
55124

Correspodent Contact rich jansen
Regulation Number 888.3080
Classification Product Code
OVD  
Date Received 09/16/2011
Decision Date 11/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No