EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE


Device Classification Name

spinal vertebral body replacement device

510(k) Number K050997
Device Name EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
Applicant
FLEXUSPINE, INC.
120 w. fifth street, suite 200
tyler, 
TX 
75701

Applicant Contact corey harbold
Correspondent
FLEXUSPINE, INC.
120 w. fifth street, suite 200
tyler, 
TX 
75701

Correspodent Contact corey harbold
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 04/20/2005
Decision Date 10/07/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No