REXIOUS SPINAL FIXATION SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K111362
Device Name REXIOUS SPINAL FIXATION SYSTEM
Applicant
DIO MEDICAL CO., LTD.
325 n. puente st
unit b
brea, 
CA 
92821

Applicant Contact april lee
Correspondent
DIO MEDICAL 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 Codes
KWP   MNI  
Date Received 05/16/2011
Decision Date 07/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No