PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K073177
Device Name PIONEER INTERVERTEBRAL FUSION DEVICE 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 888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received 11/13/2007
Decision Date 05/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls