FDA 510(k) Applications Submitted by Tornier, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090139 |
01/21/2009 |
ANKLE ARTHRODESIS PLATE SYSTEM |
TORNIER, INC. |
| K100562 |
03/01/2010 |
LATITUDE ELBOW PROSTHESIS |
TORNIER, INC. |
| K110599 |
03/02/2011 |
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM |
TORNIER, INC. |
| K090582 |
03/04/2009 |
CALCANEAL FRACTURE PLATE SYSTEM |
TORNIER, INC. |
| K120739 |
03/12/2012 |
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM |
TORNIER, INC. |
| K120794 |
03/15/2012 |
ASCEND SHOULDER SYSTEM |
TORNIER, INC. |
| K110773 |
03/21/2011 |
TORNIER INSITE FT SUTURE ANCHOR |
TORNIER, INC. |
| K110865 |
03/29/2011 |
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM |
TORNIER, INC. |
| K121493 |
05/21/2012 |
ASCEND SHOULDER SYSTEM |
TORNIER, INC. |
| K112615 |
09/08/2011 |
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM |
TORNIER, INC. |
| K102924 |
09/30/2010 |
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM |
TORNIER, INC. |
| K103007 |
10/12/2010 |
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM |
TORNIER, INC. |
| K113413 |
11/18/2011 |
ASCEND SHOULDER SYSTEM |
TORNIER, INC. |
| K150871 |
04/01/2015 |
ForeFoot STP System |
TORNIER, INC. |
| K994041 |
11/29/1999 |
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS |
TORNIER, INC. |
| K080335 |
02/07/2008 |
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM |
TORNIER, INC. |
| K111337 |
05/12/2011 |
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD |
TORNIER, INC. |
| K103262 |
11/04/2010 |
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM |
TORNIER, INC. |
| K083268 |
11/05/2008 |
TORNIER, INC., INSITE SUTURE ANCHORS |
TORNIER, INC. |
| K093799 |
12/10/2009 |
TORNIER SURGICAL MESH |
TORNIER, INC. |
| K132632 |
08/22/2013 |
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES |
TORNIER, INC. |
| K133376 |
11/04/2013 |
AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT |
TORNIER, INC. |
| K081707 |
06/17/2008 |
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS |
TORNIER, INC. |
| K150715 |
03/19/2015 |
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors |
TORNIER, INC. |
| K191318 |
05/15/2019 |
AEQUALIS FLEX REVIVE Shoulder System |
Tornier, Inc. |
| K150583 |
03/09/2015 |
Aequalis PerFORM+ Shoulder System |
TORNIER, INC. |
| K141029 |
04/22/2014 |
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM |
TORNIER, INC. |
| K130422 |
02/20/2013 |
PHANTOM FIBER BIOFIBER SUTURE |
TORNIER, INC. |
| K122487 |
08/15/2012 |
BIOFIBER SYTURE |
TORNIER, INC. |
| K122635 |
08/29/2012 |
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR |
TORNIER, INC. |
| K102788 |
09/24/2010 |
TORNIER BIOFIBER SCAFFOLD |
TORNIER, INC. |
| K181420 |
05/31/2018 |
Aequalis Flex Revive Shoulder System |
Tornier, Inc. |
| K161742 |
06/24/2016 |
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid |
Tornier, Inc. |
| K211359 |
05/03/2021 |
Tornier PerformÖ Patient-Matched Primary Reversed Glenoid and BLUEPRINTÖ Patient Specific Instrumentation |
Tornier, Inc. |
| K213124 |
09/27/2021 |
Tomier PerformÖ Reversed Glenoid Cannulated Glenospheres |
Tornier, Inc. |
| K160975 |
04/07/2016 |
Aequalis PerFORM+ Shoulder System |
TORNIER, INC. |
| K143552 |
12/15/2014 |
Simpliciti Shoulder System |
TORNIER, INC. |
| K133777 |
12/12/2013 |
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR |
TORNIER, INC. |
| K183696 |
12/31/2018 |
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid |
Tornier, Inc. |
| K220418 |
02/14/2022 |
Tornier Perform Humeral System û Stemless |
Tornier, Inc. |
| K220914 |
03/30/2022 |
Tornier Perform Humeral System û Fracture |
Tornier, Inc. |
| K201315 |
05/18/2020 |
PERFORM Humeral System û Stem |
Tornier, Inc. |
| K120262 |
01/27/2012 |
HLS UNI EVOLUTION & U-KNEETEC |
TORNIER, INC. |
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