FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

119 results for "Tornier"
25–48 of 119
Search insights Median review: 112d Cleared: 99% Top manufacturer: Tornier, Inc. Lead specialty: Orthopedic
Cleared Aug 31, 2017
Latitude EV Total Elbow Arthroplasty
K171010 · JDB
Tornier, Inc.
Orthopedic · 149d
Cleared Feb 22, 2017
BLUEPRINT Patient Specific Instrumentation
K162800 · KWS
Tornier S.A.S.
Orthopedic · 140d
Cleared Dec 27, 2016
BLUEPRINT Patient Specific Instrumentation
K161789 · KWS
Tornier S.A.S.
Orthopedic · 181d
Cleared Nov 15, 2016
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
K161742 · PHX
Tornier, Inc.
Orthopedic · 144d
Cleared Aug 11, 2016
Salto XT, Salto Talaris
K153452 · HSN
Tornier S.A.S.
Orthopedic · 255d
Cleared Jun 10, 2016
Aequalis PerFORM+ Shoulder System
K160975 · KWS
Tornier, Inc.
Orthopedic · 64d
Cleared Jun 10, 2016
BLUEPRINT Patient Specific Instrumentation
K160555 · KWS
Tornier S.A.S.
Orthopedic · 102d
Cleared Jan 14, 2016
Aequalis Fx2
K152966 · PHX
Tornier S.A.S.
Orthopedic · 99d
Cleared Sep 24, 2015
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
K151293 · KWS
Tornier S.A.S.
Orthopedic · 132d
Cleared Aug 04, 2015
ForeFoot STP System
K150871 · HWC
Tornier, Inc.
Orthopedic · 125d
Cleared Jul 28, 2015
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
K150715 · MBI
Tornier, Inc.
Orthopedic · 131d
Cleared Apr 23, 2015
Aequalis PerFORM+ Shoulder System
K150583 · KWS
Tornier, Inc.
Orthopedic · 45d
Cleared Apr 08, 2015
BLUEPRINT Patient Specific Instrumentation
K143374 · KWS
Tornier S.A.S.
Orthopedic · 134d
Cleared Mar 04, 2015
Simpliciti Shoulder System
K143552 · PKC
Tornier, Inc.
Orthopedic · 79d
Cleared Nov 18, 2014
AEQUALIS FX2
K141345 · PHX
Tornier S.A.S.
Orthopedic · 180d
Cleared Aug 06, 2014
AEQUALIS REVERSED SHOULDER PROSTHESIS
K140478 · PHX
Tornier S.A.S.
Orthopedic · 161d
Cleared Jul 18, 2014
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
K140082 · PHX
Tornier S.A.S.
Orthopedic · 186d
Cleared Jun 18, 2014
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
K141029 · PHX
Tornier, Inc.
Orthopedic · 57d
Cleared Apr 04, 2014
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133777 · MBI
Tornier, Inc.
Orthopedic · 113d
Cleared Dec 05, 2013
AEQUALIS HUMERAL NAIL
K133376 · HSB
Tornier, Inc.
Orthopedic · 31d
Cleared Dec 05, 2013
AEQUALIS REVERSED SHOULDER PROSTHESIS
K132285 · PHX
Tornier S.A.S.
Orthopedic · 135d
Cleared Oct 16, 2013
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS,...
K131231 · PHX
Tornier S.A.S.
Orthopedic · 169d
Cleared Sep 19, 2013
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132632 · MBI
Tornier, Inc.
Orthopedic · 28d
Cleared Jul 15, 2013
611 ANKLE FUSION NAIL
K130051 · HSB
Tornier S.A.S.
Orthopedic · 187d