MODIFICATION TO HIGHGATE CURVED ROD SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K023983
Device Name MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
Original Applicant
HIGHGATE ORTHOPAEDICS
7000 mill rd.
cleveland, 
OH 
44141

Original Contact karen e warden
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 12/02/2002
Decision Date 09/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No