DDS STABILIZATION SYSTEM


Device Classification Name

posterior metal/polymer spinal system, fusion

510(k) Number K080241
Device Name DDS STABILIZATION SYSTEM
Applicant
PARADIGM SPINE, LLC
1331 h street nw
12th floor
washington, 
DC 
20005

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

Correspodent Contact justin eggleton
Regulation Number 888.3070
Classification Product Code
NQP  
Date Received 01/31/2008
Decision Date 11/28/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No