SYNTHES STERNAL ZIPFIX SYSTEM


Device Classification Name

cerclage, fixation

510(k) Number K110789
Device Name SYNTHES STERNAL ZIPFIX SYSTEM
Applicant
SYNTHES (USA)
1301 goshen parkwya
west chester, 
PA 
19380

Applicant Contact andrea m tasker
Correspondent
SYNTHES (USA)
1301 goshen parkwya
west chester, 
PA 
19380

Correspodent Contact andrea m tasker
Regulation Number 888.3010
Classification Product Code
JDQ  
Date Received 03/22/2011
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls