PATHWAY MODEL 07XXXX


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K111774
Device Name PATHWAY MODEL 07XXXX
Applicant
CUSTOM SPINE
1140 parsippany blvd, suite 20
parsippany, 
NJ 
07054

Applicant Contact saad attiyah
Correspondent
CUSTOM SPINE
1140 parsippany blvd, suite 20
parsippany, 
NJ 
07054

Correspodent Contact saad attiyah
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 06/23/2011
Decision Date 07/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No