ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K023994
Device Name ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
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 Codes
KWP   MNI  
Date Received 12/03/2002
Decision Date 02/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No