SHELL CAGE, WAVE CAGE, LOOP CAGE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080401
Device Name SHELL CAGE, WAVE CAGE, LOOP CAGE
Applicant
ADVANCED MEDICAL TECHNOLOGIES AG
1001 oakwood blvd.
round rock, 
TX 
78681

Applicant Contact j.d. webb
Correspondent
ADVANCED MEDICAL TECHNOLOGIES AG
1001 oakwood blvd.
round rock, 
TX 
78681

Correspodent Contact j.d. webb
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received 02/14/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No