DEVINE SPINAL SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K111690
Device Name DEVINE SPINAL SYSTEM
Applicant
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Applicant Contact diana hong
Correspondent
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Correspodent Contact diana hong
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 06/16/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No