AXLE PEEK INTERSPINOUS FUSION SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K112592
Device Name AXLE PEEK INTERSPINOUS FUSION 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 888.3050
Classification Product Code
KWP  
Date Received 09/07/2011
Decision Date 12/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No