ORTHOMESH


Device Classification Name

plate, fixation, bone

510(k) Number K073115
Device Name ORTHOMESH
Applicant
SYNTHES (USA)
1230 wilson drive
west chester, 
PA 
19380

Applicant Contact jeffrey l dow
Correspondent
SYNTHES (USA)
1230 wilson drive
west chester, 
PA 
19380

Correspodent Contact jeffrey l dow
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 11/05/2007
Decision Date 07/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No