BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K111512
Device Name BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
Applicant
THOMPSON MIS INC
45 stiles rd
suite 210
salem, 
NH 
03079

Applicant Contact frank sullivan
Correspondent
THOMPSON MIS INC
45 stiles rd
suite 210
salem, 
NH 
03079

Correspodent Contact frank sullivan
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 06/01/2011
Decision Date 10/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No