ORIA CLARIS


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K023378
Device Name ORIA CLARIS
Original Applicant
ORTHOTEC, L.L.C.
9595 wilshire blvd. suite 502
beverly hills, 
CA 
90212

Original Contact patrick bertranou
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 10/08/2002
Decision Date 06/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No