MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K080075
Device Name MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
Applicant
ELITE SURGICAL SUPPLIES (PTY) LTD.
503 commerce park drive
suite 1
marietta, 
GA 
30060

Applicant Contact charise de barros
Correspondent
ELITE SURGICAL SUPPLIES (PTY) LTD.
503 commerce park drive
suite 1
marietta, 
GA 
30060

Correspodent Contact charise de barros
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received 01/11/2008
Decision Date 01/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No