PATHWAY


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080281
Device Name PATHWAY
Applicant
CUSTOM SPINE, INC.
1140 parsippany blvd.
suite 201
parsippany, 
NJ 
07054

Applicant Contact saad attiyah
Correspondent
CUSTOM SPINE, INC.
1140 parsippany blvd.
suite 201
parsippany, 
NJ 
07054

Correspodent Contact saad attiyah
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 02/04/2008
Decision Date 05/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No