SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES


Device Classification Name

plate, fixation, bone

510(k) Number K073460
Device Name SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
Applicant
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact sheri l musgnung
Correspondent
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact sheri l musgnung
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 12/10/2007
Decision Date 02/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No