MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM


Device Classification Name

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

510(k) Number K030372
Device Name MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
Applicant
EBI, L.P.
399 jefferson road
parsippany, 
NJ 
07054

Applicant Contact frederic testa
Correspondent
EBI, L.P.
399 jefferson road
parsippany, 
NJ 
07054

Correspodent Contact frederic testa
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 02/04/2003
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