QUANTUM-MIS CANNULATED SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K080026
Device Name QUANTUM-MIS CANNULATED SYSTEM
Applicant
PIONEER SURGICAL TECHNOLOGY
375 river park circle
marquette, 
MI 
49855 -0627

Applicant Contact jonathan m gilbert
Correspondent
PIONEER SURGICAL TECHNOLOGY
375 river park circle
marquette, 
MI 
49855 -0627

Correspodent Contact jonathan m gilbert
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 01/04/2008
Decision Date 01/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No