ZEPHIR ANTERIOR CERVICAL SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K030327
Device Name ZEPHIR ANTERIOR CERVICAL SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Original Contact richard treharne
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 01/31/2003
Decision Date 02/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No