LDR SPINE ROI-A INTERBODY FUSION SYSTEM


Device Classification Name

intervertebral fusion device with integrated fixation, lumbar

510(k) Number K110327
Device Name LDR SPINE ROI-A INTERBODY FUSION SYSTEM
Applicant
LDR SPINE USA
4030 west braker lane
suite 360
austin, 
TX 
78759

Applicant Contact maritza elias
Correspondent
LDR SPINE USA
4030 west braker lane
suite 360
austin, 
TX 
78759

Correspodent Contact maritza elias
Regulation Number 888.3080
Classification Product Code
OVD  
Date Received 02/03/2011
Decision Date 09/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No