ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K030252
Device Name ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
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 01/24/2003
Decision Date 02/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No