BIOFASTIN RC THREADED SUTURE ANCHOR


Device Classification Name

screw, fixation, bone

510(k) Number K021883
Device Name BIOFASTIN RC THREADED SUTURE ANCHOR
Original Applicant
MITEK WORLDWIDE
249 vanderbilt ave.
norwood, 
MA 
02062

Original Contact ruth c forstadt
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Codes
GAM   GAS   MAI  
Date Received 06/07/2002
Decision Date 07/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No