Medical Device Manufacturer · US , Beverly , MA

Tornier, Inc. - FDA 510(k) Cleared Devices

51 submissions · 51 cleared · Since 2000
51
Total
51
Cleared
0
Denied
46 devices
26-46 of 46
Cleared Sep 19, 2013
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132632 · MBI
Orthopedic · 28d
Cleared May 13, 2013
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
K122635 · MAI
Orthopedic · 257d
Cleared Jul 25, 2012
HLS UNI EVOLUTION & U-KNEETEC
K120262 · HSX
Orthopedic · 180d
Cleared Jul 05, 2012
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
K120739 · PHX
Orthopedic · 115d
Cleared Jun 20, 2012
ASCEND SHOULDER SYSTEM
K121493 · KWS
Orthopedic · 30d
Cleared Apr 13, 2012
ASCEND SHOULDER SYSTEM
K120794 · KWS
Orthopedic · 29d
Cleared Mar 09, 2012
ASCEND SHOULDER SYSTEM
K113413 · KWS
Orthopedic · 112d
Cleared Oct 11, 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K112615 · PHX
Orthopedic · 33d
Cleared Jun 14, 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K110599 · PHX
Orthopedic · 104d
Cleared Jun 02, 2011
TORNIER INSITE FT SUTURE ANCHOR
K110773 · MBI
Orthopedic · 73d
Cleared Apr 27, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K110865 · KWS
Orthopedic · 29d
Cleared Apr 05, 2011
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
K103262 · MBI
Orthopedic · 152d
Cleared Jan 31, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K102924 · KWS
Orthopedic · 123d
Cleared Nov 09, 2010
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
K103007 · KWS
Orthopedic · 28d
Cleared Jun 29, 2010
LATITUDE ELBOW PROSTHESIS
K100562 · JDB
Orthopedic · 120d
Cleared Oct 27, 2009
ANKLE ARTHRODESIS PLATE SYSTEM
K090139 · HRS
Orthopedic · 279d
Cleared Jul 02, 2009
CALCANEAL FRACTURE PLATE SYSTEM
K090582 · HRS
Orthopedic · 120d
Cleared Feb 12, 2009
TORNIER, INC., INSITE SUTURE ANCHORS
K083268 · MAI
Orthopedic · 99d
Cleared Jul 17, 2008
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
K081707 · KWS
Orthopedic · 30d
Cleared Apr 23, 2008
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K080335 · MBI
Orthopedic · 76d
Cleared Aug 31, 2000
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
K994041 · KWI
Orthopedic · 276d
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