Medical Device Manufacturer · US , Concord , CA

Tornier

44 submissions · 44 cleared · Since 1995
44
Total
44
Cleared
0
Denied

Tornier — FDA 510(k) Submissions

Tornier has submitted 44 FDA 510(k) premarket notifications since 1995, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented, Shoulder Prosthesis, Reverse Configuration, Prosthesis, Elbow, Semi-constrained, Cemented, Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer . Use the specialty filter in the sidebar to narrow results.

44 devices
1–25 of 44
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
K112144 · PHX Shoulder Prosthesis,... · Orthopedic
Mar 2012 231d
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
K111970 · KRR Prosthesis, Knee,... · Orthopedic
Feb 2012 227d
AEQUALIS SHOULDER SYSTEM
K111902 · KWS Prosthesis, Shoulder,... · Orthopedic
Nov 2011 121d
HLS KNEETEC SYSTEM
K094013 · JWH Prosthesis, Knee,... · Orthopedic
May 2011 492d
AEQUALIS REVERSED SHOULDER PROSTHESIS
K100142 · PHX Shoulder Prosthesis,... · Orthopedic
May 2010 107d
TORNIER, PITON FIXATION IMPLANT SYSTEM
K091870 · MBI Fastener, Fixation,... · Orthopedic
Sep 2009 90d
SALTO TALARIS TOTAL ANKLE PROSTHESIS
K090076 · HSN Prosthesis, Ankle,... · Orthopedic
Mar 2009 64d
AEQUALIS HUMERAL NAIL SYSTEM
K082754 · HSB Rod, Fixation,... · Orthopedic
Jan 2009 130d
AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
K082120 · KWS Prosthesis, Shoulder,... · Orthopedic
Oct 2008 88d
AEQUALIS REVERSED SHOULDER PROSTHESIS
K081059 · PHX Shoulder Prosthesis,... · Orthopedic
Jul 2008 94d
AEQUALIS REVERSED ADAPTER
K071948 · PHX Shoulder Prosthesis,... · Orthopedic
Oct 2007 97d
LATITUDE ELBOW PROTHESIS
K070787 · JDB Prosthesis, Elbow,... · Orthopedic
Aug 2007 155d
AEQUALIS RESURFACING HEAD
K062661 · HSD Prosthesis, Shoulder,... · Orthopedic
Dec 2006 106d
AEQUALIS HUMERAL PLATE
K063551 · KTT Appliance, Fixation,... · Orthopedic
Dec 2006 28d
SALTO TALARIS TOTAL ANKLE PROSTHESIS
K060544 · HSN Prosthesis, Ankle,... · Orthopedic
Nov 2006 257d
AEQUALIS SHOULDER SYSTEM
K063081 · HSD Prosthesis, Shoulder,... · Orthopedic
Nov 2006 30d
TORNIER CEMENT RESTRICTOR
K061824 · LZN Cement Obturator · Orthopedic
Sep 2006 78d
AEQUALIS REVERSED PROSTHESIS
K061439 · PHX Shoulder Prosthesis,... · Orthopedic
Jul 2006 57d
UNITY HUMERAL PLATE
K060545 · KTT Appliance, Fixation,... · Orthopedic
Apr 2006 51d
RHS
K060438 · JDB Prosthesis, Elbow,... · Orthopedic
Apr 2006 56d
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
K060209 · KWS Prosthesis, Shoulder,... · Orthopedic
Mar 2006 34d
TORNIER ELBOW PROSTHESIS
K050848 · JDB Prosthesis, Elbow,... · Orthopedic
Jul 2005 101d
AEQUALIS REVERSED SHOULDER PROSTHESIS
K050316 · PHX Shoulder Prosthesis,... · Orthopedic
Mar 2005 35d
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM
K043077 · KWS Prosthesis, Shoulder,... · Orthopedic
Dec 2004 39d
AEQUALIS REVERSED SHOULDER PROSTHESIS
K041873 · PHX Shoulder Prosthesis,... · Orthopedic
Aug 2004 44d
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