CALIX PC SPINAL IMPLANT SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K112036
Device Name CALIX PC 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 888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received 07/18/2011
Decision Date 11/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No