GIZA(R) VERTEBRAL BODY REPLACEMENT


Device Classification Name

spinal vertebral body replacement device

510(k) Number K112429
Device Name GIZA(R) VERTEBRAL BODY REPLACEMENT
Applicant
EDEN SPINE, LLC
13540 guild ave
apple valley, 
MN 
55124

Applicant Contact rich jansen
Correspondent
EDEN SPINE, LLC
13540 guild ave
apple valley, 
MN 
55124

Correspodent Contact rich jansen
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 08/23/2011
Decision Date 01/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No