MEDICAL CONCEPTS INTERBODY FUSION SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K110659
Device Name MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
Applicant
MEDICAL CONCEPTS, INC.
11467 huebner rd
suite #350
san antonio, 
TX 
78230

Applicant Contact christopher canis
Correspondent
MEDICAL CONCEPTS, INC.
11467 huebner rd
suite #350
san antonio, 
TX 
78230

Correspodent Contact christopher canis
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP  
Date Received 03/07/2011
Decision Date 09/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No