PIONEER SPINAL PROCESS FUSION PLATE


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K110367
Device Name PIONEER SPINAL PROCESS FUSION PLATE
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 888.3050
Classification Product Code
KWP  
Date Received 02/08/2011
Decision Date 03/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No