MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K121569
Device Name MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
Applicant
ACCEL SPINE
14850 quorum dr ste 220
dallas, 
TX 
75254

Applicant Contact daniel chon
Correspondent
ACCEL SPINE
14850 quorum dr ste 220
dallas, 
TX 
75254

Correspodent Contact daniel chon
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 05/29/2012
Decision Date 07/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No