PIONEER CROSSFUSE II IBF/VBR SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K112496
Device Name PIONEER CROSSFUSE II IBF/VBR SYSTEM
Applicant
PIONEER SURGICAL TECHNOLOGY, INC.
375 river park circle
marquette, 
MI 
49855

Applicant Contact emily m downs
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC.
375 river park circle
marquette, 
MI 
49855

Correspodent Contact emily m downs
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP  
Date Received 08/29/2011
Decision Date 09/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No