DSS STABILIZATION SYSTEM


Device Classification Name

posterior metal/polymer spinal system, fusion

510(k) Number K080963
Device Name DSS STABILIZATION SYSTEM
Applicant
PARADIGM SPINE
1331 h street nw
12th floor
washington, 
DC 
20005

Applicant Contact justin eggleton
Correspondent
PARADIGM SPINE
1331 h street nw
12th floor
washington, 
DC 
20005

Correspodent Contact justin eggleton
Regulation Number 888.3070
Classification Product Code
NQP  
Date Received 04/04/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No