Tornier S.A.S. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Tornier S.A.S. - FDA 510(k) Cleared Devices
Recent clearances: BLUEPRINT™ Patient Specific Instrumentation, Blueprint Mixed Reality system, BLUEPRINT™ Patient Specific Instrumentation
20
Total
19
Cleared
1
Denied
Tornier S.A.S. has 19 FDA 510(k) cleared orthopedic devices. Based in Bloomington, US.
Latest FDA clearance: Feb 2024. Active since 2013.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Tornier S.A.S.
20 devices
Cleared
Feb 21, 2024
BLUEPRINT™ Patient Specific Instrumentation
Orthopedic
205d
Cleared
Jan 20, 2023
Blueprint Mixed Reality system
Orthopedic
154d
Not Cleared
Dec 16, 2022
Tornier Pyrocarbon Humeral Head
Orthopedic
311d
Cleared
Apr 15, 2021
BLUEPRINT™ Patient Specific Instrumentation
Orthopedic
156d
Cleared
Jun 12, 2019
Aequalis Ascend Flex Shoulder System
Orthopedic
100d
Cleared
Feb 22, 2017
BLUEPRINT Patient Specific Instrumentation
Orthopedic
140d
Cleared
Dec 27, 2016
BLUEPRINT Patient Specific Instrumentation
Orthopedic
181d
Cleared
Aug 11, 2016
Salto XT, Salto Talaris
Orthopedic
255d
Cleared
Jun 10, 2016
BLUEPRINT Patient Specific Instrumentation
Orthopedic
102d
Cleared
Jan 14, 2016
Aequalis Fx2
Orthopedic
99d
Cleared
Sep 24, 2015
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
Orthopedic
132d
Cleared
Apr 08, 2015
BLUEPRINT Patient Specific Instrumentation
Orthopedic
134d
Cleared
Nov 18, 2014
AEQUALIS FX2
Orthopedic
180d
Cleared
Aug 06, 2014
AEQUALIS REVERSED SHOULDER PROSTHESIS
Orthopedic
161d
Cleared
Jul 18, 2014
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
Orthopedic
186d
Cleared
Dec 05, 2013
AEQUALIS REVERSED SHOULDER PROSTHESIS
Orthopedic
135d
Cleared
Oct 16, 2013
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS,...
Orthopedic
169d
Cleared
Jul 15, 2013
611 ANKLE FUSION NAIL
Orthopedic
187d
Cleared
May 17, 2013
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
Orthopedic
77d
Cleared
Jan 08, 2013
AEQUALIS ASCEND FLEX SHOULDER SYSTEM
Orthopedic
126d