PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K111528
Device Name PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
Applicant
PIONEER SURGICAL TECHNOLOGY, INC
375 river park circle
marquette, 
MI 
49855

Applicant Contact sarah mcintyre
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC
375 river park circle
marquette, 
MI 
49855

Correspodent Contact sarah mcintyre
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 06/02/2011
Decision Date 08/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No