ASCENSION ATLAS HUMERAL PLATING SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K110700
Device Name ASCENSION ATLAS HUMERAL PLATING SYSTEM
Applicant
ASCENSION ORTHOPEDICS, INC.
8700 cameron rd., ste. 100
austin, 
TX 
78754 -3832

Applicant Contact susan walton
Correspondent
ASCENSION ORTHOPEDICS, INC.
8700 cameron rd., ste. 100
austin, 
TX 
78754 -3832

Correspodent Contact susan walton
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 03/14/2011
Decision Date 12/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No