MITEK PDS/PGA STAPLE


Device Classification Name

staple, fixation, bone

510(k) Number K021953
Device Name MITEK PDS/PGA STAPLE
Original Applicant
MITEK WORLDWIDE
249 vanderbilt ave.
norwood, 
MA 
02062

Original Contact petra c smit
Regulation Number 888.3030
Classification Product Code
JDR  
Date Received 06/13/2002
Decision Date 12/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No