4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM


Device Classification Name

condylar plate fixation implant

510(k) Number K110354
Device Name 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
Applicant
SYNTHES USA
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact thomas n shea
Correspondent
SYNTHES USA
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact thomas n shea
Regulation Number 888.3030
Classification Product Code
JDP  
Subsequent Product Codes
HRS   HWC  
Date Received 02/07/2011
Decision Date 03/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls