SYNTHES PATIENT SPECIFIC PLATE


Device Classification Name

plate, bone

510(k) Number K122647
Device Name SYNTHES PATIENT SPECIFIC PLATE
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 872.4760
Classification Product Code
JEY  
Date Received 08/30/2012
Decision Date 02/28/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No