MODIFICATION ORIA SPINAL SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K023884
Device Name MODIFICATION ORIA SPINAL SYSTEM
Original Applicant
ORTHOTEC, L.L.C.
9595 wilshire blvd. suite 502
beverly hills, 
CA 
90212

Original Contact patrick bertranou
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received 11/21/2002
Decision Date 08/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No