HOURGLASS VERTEBRAL BODY SPACER

Device Classification Name

spinal vertebral body replacement device

510(k) Number K033926
Device Name HOURGLASS VERTEBRAL BODY SPACER
Applicant
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact richard treharne
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact richard treharne
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 12/18/2003
Decision Date 07/07/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No