AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS


Device Classification Name

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

510(k) Number K112144
Device Name AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
Applicant
TORNIER
161 rue lavoisier
montbonnot, saint-ismier, 

FR

38334

Applicant Contact severine bonneton
Correspondent
TORNIER
161 rue lavoisier
montbonnot, saint-ismier, 

FR

38334

Correspodent Contact severine bonneton
Regulation Number 888.3660
Classification Product Code
KWS  
Date Received 07/26/2011
Decision Date 03/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No