NUGEN FX SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K023022
Device Name NUGEN FX SCREW
Original Applicant
BIONX IMPLANTS, INC.
1777 sentry pkwy. west,
gwynedd hall, suite 400
blue bell, 
PA 
19422

Original Contact gerard s carlozzi
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 09/11/2002
Decision Date 10/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No