GPS, G SURGICAL PEDICLE SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K081041
Device Name GPS, G SURGICAL PEDICLE SYSTEM
Applicant
G SURGICAL CO., LTD.
152 soi ramkhamhaeng 138
sapansung
bangkok, 

TH

10240

Applicant Contact donald grafton
Correspondent
G SURGICAL CO., LTD.
152 soi ramkhamhaeng 138
sapansung
bangkok, 

TH

10240

Correspodent Contact donald grafton
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received 04/11/2008
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No