Tornier - FDA 510(k) Cleared Devices
44
Total
44
Cleared
0
Denied
43 devices
Cleared
Jun 17, 2004
AEQUALIS SHOULDER SYSTEM
Orthopedic
28d
Cleared
May 14, 2004
AEQUALIS REVERSED SHOULDER PROSTHESIS
Orthopedic
416d
Cleared
Dec 15, 2003
AEQUALIS SHOULDER FRACTURE SYSTEM
Orthopedic
108d
Cleared
Oct 02, 2003
HLS NOETOS SYSTEM
Orthopedic
87d
Cleared
May 22, 2003
HLS UNI EVOLUTION PROSTHESIS
Orthopedic
318d
Cleared
May 16, 2003
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
Orthopedic
29d
Cleared
Jul 17, 2002
HLS NOETOS SYSTEM
Orthopedic
233d
Cleared
Aug 15, 2001
MODIFICATION TO AEQUALIS SHOULDER SYSTEM
Orthopedic
30d
Cleared
Jul 13, 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
Orthopedic
22d
Cleared
Jun 19, 2001
TORNIER TOTAL ELBOW PROSTHESIS
Orthopedic
29d
Cleared
Dec 20, 2000
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
Orthopedic
16d
Cleared
Oct 02, 2000
TORNIER TOTAL ELBOW PROSTHESIS
Orthopedic
273d
Cleared
Jul 20, 2000
TORNIER CEMENT RESTRICTOR
Orthopedic
24d
Cleared
Jun 22, 2000
AEQUALIS UNIVERSAL SHOULDER GLENOID
Orthopedic
177d
Cleared
Mar 10, 2000
AEQUALIS SHOULDER FRACTURE SYSTEM
Orthopedic
73d
Cleared
Aug 23, 1999
AEQUALIS SHOULDER PROSTHESIS
Orthopedic
577d
Cleared
Dec 22, 1998
PHUSIS ABSORBABLE INTERFERENCE SCREW
Orthopedic
656d
Cleared
Sep 27, 1995
AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS
Orthopedic
93d