TURBO PRIME IBD SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080058
Device Name TURBO PRIME IBD SYSTEM
Applicant
SPINE SELECT, LLC
13540 guild ave
apple valley, 
MN 
55124

Applicant Contact richard jansen
Correspondent
SPINE SELECT, LLC
13540 guild ave
apple valley, 
MN 
55124

Correspodent Contact richard jansen
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 01/09/2008
Decision Date 04/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No