LDR SPINE ROI-C IMPLANT


Device Classification Name

spinal vertebral body replacement device

510(k) Number K080728
Device Name LDR SPINE ROI-C IMPLANT
Applicant
LDR SPINE USA
4030 west braker lane
suite 360
austin, 
TX 
78759

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

Correspodent Contact noah bartsch
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 03/14/2008
Decision Date 05/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No