INFILL GRAFT DELIVERY SYSTEM


Device Classification Name

syringe, piston

510(k) Number K111632
Device Name INFILL GRAFT DELIVERY SYSTEM
Applicant
PINNACLE SPINE GROUP, LLC
1601 elm street, suite 300
dallas, 
TX 
75201

Applicant Contact rebecca k spine
Correspondent
PINNACLE SPINE GROUP, LLC
1601 elm street, suite 300
dallas, 
TX 
75201

Correspodent Contact rebecca k spine
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 06/13/2011
Decision Date 08/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No