PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K121725
Device Name PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
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 888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received 06/12/2012
Decision Date 11/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No