BUTREX BUTTRESS PLATING SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K072943
Device Name BUTREX BUTTRESS PLATING SYSTEM
Applicant
X-SPINE SYSTEMS, INC.
452 alexandersville rd.
miamisburg, 
OH 
45342

Applicant Contact david kirschman
Correspondent
X-SPINE SYSTEMS, INC.
452 alexandersville rd.
miamisburg, 
OH 
45342

Correspodent Contact david kirschman
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 10/17/2007
Decision Date 01/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No