EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K021695
Device Name EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
Original Applicant
EBI, L.P.
399 jefferson road
parsippany, 
NJ 
07054

Original Contact patricia m flood
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 05/22/2002
Decision Date 06/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No