APEX KIRSCHNER WIRES AND STEINMANN PINS


Device Classification Name

pin, fixation, smooth

510(k) Number K112254
Device Name APEX KIRSCHNER WIRES AND STEINMANN PINS
Applicant
APEX TOOLS & ORTHOPEDICS CO.
25 yonghua, yonghe,
getdd
guangzhou, guangdong, 

CN

cn-511356

Applicant Contact scott liang
Correspondent
APEX TOOLS & ORTHOPEDICS CO.
25 yonghua, yonghe,
getdd
guangzhou, guangdong, 

CN

cn-511356

Correspodent Contact scott liang
Regulation Number 888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received 08/05/2011
Decision Date 10/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No