CERTEX SPINAL IMPLANT SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K122163
Device Name CERTEX SPINAL IMPLANT 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 888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received 07/20/2012
Decision Date 10/31/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No