STAXXSD SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K111469
Device Name STAXXSD SYSTEM
Applicant
SPINE WAVE, INC.
3 enterprise dr
suite 210
shelton, 
CT 
06484

Applicant Contact denise duchene
Correspondent
SPINE WAVE, INC.
3 enterprise dr
suite 210
shelton, 
CT 
06484

Correspodent Contact denise duchene
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 05/27/2011
Decision Date 07/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No