MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM


Device Classification Name

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

510(k) Number K024248
Device Name MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM
Original Applicant
EBI, L.P.
399 jefferson road
parsippany, 
NJ 
07054

Original Contact frederic testa
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 12/23/2002
Decision Date 01/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No