PIONEER LOWTOP SPINAL ROD SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K072187
Device Name PIONEER LOWTOP SPINAL ROD 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 08/06/2007
Decision Date 10/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No