XINGTM SPINE SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K111995
Device Name XINGTM SPINE SYSTEM
Applicant
IMPLANOVA CO. LTD
325 n. puente st unit b
brea, 
CA 
92821

Applicant Contact april lee
Correspondent
IMPLANOVA CO. LTD
325 n. puente st unit b
brea, 
CA 
92821

Correspodent Contact april lee
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 07/13/2011
Decision Date 12/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No