PIONEER STERNAL CABLE PLATE SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K122293
Device Name PIONEER STERNAL CABLE PLATE 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 888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDQ  
Date Received 07/31/2012
Decision Date 10/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No