APTUS(R) DISTAL HUMERUS SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K112560
Device Name APTUS(R) DISTAL HUMERUS SYSTEM
Applicant
MEDARTIS AG
11234 el camino real
suite 200
san diego, 
CA 
92130

Applicant Contact kevin a thomas
Correspondent
MEDARTIS AG
11234 el camino real
suite 200
san diego, 
CA 
92130

Correspodent Contact kevin a thomas
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 09/02/2011
Decision Date 12/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No