ORIA CERVICAL PLATES


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K023377
Device Name ORIA CERVICAL PLATES
Original Applicant
ORTHOTEC, L.L.C.
9595 wilshire blvd. suite 502
beverly hills, 
CA 
90212

Original Contact patrick bertranou
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 10/08/2002
Decision Date 03/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No