TITAN MODULAR TOTAL SHOULDER SYSTEM


Device Classification Name

prosthesis, shoulder, semi-constrained, metal/polymer cemented

510(k) Number K112438
Device Name TITAN MODULAR TOTAL SHOULDER SYSTEM
Applicant
ASCENSION ORTHOPEDIC
8700 cameron rd., ste. 100
austin, 
TX 
78754

Applicant Contact susan walton
Correspondent
ASCENSION ORTHOPEDIC
8700 cameron rd., ste. 100
austin, 
TX 
78754

Correspodent Contact susan walton
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received 08/24/2011
Decision Date 04/11/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No