PROW FUSION


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K112359
Device Name PROW FUSION
Applicant
NLT SPINE LTD
555 thirteenth street nw
washington, 
DC 
20004

Applicant Contact john j smith
Correspondent
NLT SPINE LTD
555 thirteenth street nw
washington, 
DC 
20004

Correspodent Contact john j smith
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 08/16/2011
Decision Date 11/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No