ORIA ZENITH


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K030500
Device Name ORIA ZENITH
Applicant
ORTHOTEC, L.L.C.
9595 wilshire blvd. suite 502
beverly hills, 
CA 
90212

Applicant Contact patrick bertranou
Correspondent
ORTHOTEC, L.L.C.
9595 wilshire blvd. suite 502
beverly hills, 
CA 
90212

Correspodent Contact patrick bertranou
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 02/19/2003
Decision Date 03/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No