2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K110125
Device Name 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
Applicant
SYNTHES USA
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact christopher hack, esq.
Correspondent
SYNTHES USA
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact christopher hack, esq.
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 01/18/2011
Decision Date 04/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No