VISUALIF CHALLENGING ACCESS PLATE


Device Classification Name

intervertebral fusion device with integrated fixation, lumbar

510(k) Number K122168
Device Name VISUALIF CHALLENGING ACCESS PLATE
Applicant
SPINE SMITH PARTNERS L.P.
93 red river
austin, 
TX 
78701

Applicant Contact clifton naivar
Correspondent
SPINE SMITH PARTNERS L.P.
93 red river
austin, 
TX 
78701

Correspodent Contact clifton naivar
Regulation Number 888.3080
Classification Product Code
OVD  
Date Received 07/23/2012
Decision Date 10/11/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No