MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K023204
Device Name MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
Original Applicant
EBI, L.P.
399 jefferson road
parsippany, 
NJ 
07054

Original Contact frederic testa
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received 09/25/2002
Decision Date 10/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No