FDA 510(k) Application Details - K050848

Device Classification Name	Prosthesis, Elbow, Semi-Constrained, Cemented   More FDA Info for this Device
510(K) Number	K050848
Device Name	Prosthesis, Elbow, Semi-Constrained, Cemented
Applicant	TORNIER 161 RUE LAVOISIER MONTBONNOT, SAINT-ISMIER 38334 FR Other 510(k) Applications for this Company
Contact	Mireille Lemery Other 510(k) Applications for this Contact
Regulation Number	888.3160   More FDA Info for this Regulation Number
Classification Product Code	JDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2005
Decision Date	07/14/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review