L-VARLOCK


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080537
Device Name L-VARLOCK
Applicant
KISCOMEDICA S.A.
1001 oakwood blvd
round rock, 
TX 
78681

Applicant Contact j.d. webb
Correspondent
KISCOMEDICA S.A.
1001 oakwood blvd
round rock, 
TX 
78681

Correspodent Contact j.d. webb
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 02/27/2008
Decision Date 06/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No