INFILL INTERVERTEBRAL BODY FUSION DEVICE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K103729
Device Name INFILL INTERVERTEBRAL BODY FUSION DEVICE
Applicant
PINNACLE SPINE GROUP, LLC
1601 elm street, suite 300
dallas, 
TX 
75201

Applicant Contact rebecca k pine
Correspondent
PINNACLE SPINE GROUP, LLC
1601 elm street, suite 300
dallas, 
TX 
75201

Correspodent Contact rebecca k pine
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 12/22/2010
Decision Date 04/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No