CONSTRUX MINI PEEK TI SPACER SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K121649
Device Name CONSTRUX MINI PEEK TI SPACER SYSTEM
Applicant
ORTHOFIX
3451 plano parkway
lewisville, 
TX 
75056

Applicant Contact natalia volosen
Correspondent
ORTHOFIX
3451 plano parkway
lewisville, 
TX 
75056

Correspodent Contact natalia volosen
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 06/05/2012
Decision Date 11/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No