SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS


Device Classification Name

material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction

510(k) Number K111323
Device Name SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
Applicant
SYNTHES INC
1301 goshen parkway
west chester, 
PA 
19380

Applicant Contact alan t haley
Correspondent
SYNTHES INC
1301 goshen parkway
west chester, 
PA 
19380

Correspodent Contact alan t haley
Regulation Number 878.3500
Classification Product Code
KKY  
Date Received 05/11/2011
Decision Date 11/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No