AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM


Device Classification Name

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

510(k) Number K110599
Device Name AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
Applicant
TORNIER, INC.
7701 france ave south
suite 600
edina, 
MN 
55435

Applicant Contact brahim hadri
Correspondent
TORNIER, INC.
7701 france ave south
suite 600
edina, 
MN 
55435

Correspodent Contact brahim hadri
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   KWT  
Date Received 03/02/2011
Decision Date 06/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No