KMEDIC EXTERNAL FIXATION DEVICES


Device Classification Name

pin, fixation, threaded

510(k) Number K030336
Device Name KMEDIC EXTERNAL FIXATION DEVICES
Original Applicant
TELEFLEX MEDICAL GROUP
50 plantation dr.
jaffrey, 
NH 
03452

Original Contact rick lykins
Regulation Number 888.3040
Classification Product Code
JDW  
Subsequent Product Code
HTY  
Date Received 01/31/2003
Decision Date 03/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No