SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K111880
Device Name SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
Applicant
Spineology Inc.
7800 third street n.
suite 600
saint paul, 
MN 
55128

Applicant Contact bryan becker
Correspondent
Spineology Inc.
7800 third street n.
suite 600
saint paul, 
MN 
55128

Correspodent Contact bryan becker
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 07/01/2011
Decision Date 09/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No