Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

56 results for "Tornier, Inc."
1–24 of 56
Search insights Median review: 112d Cleared: 100% Top manufacturer: Tornier, Inc. Lead specialty: Orthopedic
Cleared Oct 28, 2026
Tornier Humeral Reconstruction System (HRS) Tuberosity Body
K263583 · KWS
Tornier, Inc.
Orthopedic · 28d
Cleared Jul 22, 2026
Tornier Perform Advanced Glenoid
K260721 · KWS
Tornier, Inc.
Orthopedic · 139d
Cleared Jun 12, 2026
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented...
K260102 · PHX
Stryker Corporation (Tornier, Inc.)
Orthopedic · 150d
Cleared Jan 08, 2026
Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)
K252788 · PHX
Tornier, Inc.
Orthopedic · 128d
Cleared Oct 30, 2025
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
K251686 · KWT
Tornier, Inc.
Orthopedic · 150d
Cleared Dec 06, 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241878 · KWS
Stryker Corporation (Tornier, Inc.)
Orthopedic · 161d
Cleared Sep 10, 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241609 · KWS
Stryker Corporation (Tornier, Inc.)
Orthopedic · 97d
Cleared Oct 31, 2023
Tornier Humeral Nail and Tornier Long Humeral Nail
K230352 · HSB
Tornier, Inc.
Orthopedic · 264d
Cleared Oct 14, 2022
Tornier Perform Humeral System – Fracture
K220914 · PHX
Tornier, Inc.
Orthopedic · 198d
Cleared Sep 14, 2022
Tornier Perform Humeral System – Stemless
K220418 · PKC
Tornier, Inc.
Orthopedic · 212d
Cleared Nov 12, 2021
Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™...
K211359 · PHX
Tornier, Inc.
Orthopedic · 193d
Cleared Oct 26, 2021
Tomier Perform™ Reversed Glenoid Cannulated Glenospheres
K213124 · PHX
Tornier, Inc.
Orthopedic · 29d
Cleared Sep 11, 2020
PERFORM Humeral System – Stem
K201315 · PAO
Tornier, Inc.
Orthopedic · 116d
Cleared Aug 05, 2020
LATITUDE EV™ Total Elbow Arthroplasty
K193247 · JDB
Tornier, Inc.
Orthopedic · 254d
Cleared Jul 17, 2019
ORTHOLOC™ SPS Shoulder Plating System
K191711 · HRS
Tornier, Inc.
Orthopedic · 21d
Cleared Jun 14, 2019
AEQUALIS FLEX REVIVE Shoulder System
K191318 · KWS
Tornier, Inc.
Orthopedic · 30d
Cleared Jan 30, 2019
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
K183696 · PHX
Tornier, Inc.
Orthopedic · 30d
Cleared Dec 27, 2018
LATITUDE EV Total Elbow Arthroplasty
K182461 · JDB
Tornier, Inc.
Orthopedic · 108d
Cleared Oct 05, 2018
ORTHOLOC SPS Shoulder Plating System
K181587 · HRS
Tornier, Inc.
Orthopedic · 112d
Cleared Sep 20, 2018
Aequalis Flex Revive Shoulder System
K181420 · KWS
Tornier, Inc.
Orthopedic · 112d
Cleared Aug 31, 2017
Latitude EV Total Elbow Arthroplasty
K171010 · JDB
Tornier, Inc.
Orthopedic · 149d
Cleared Nov 15, 2016
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
K161742 · PHX
Tornier, Inc.
Orthopedic · 144d
Cleared Jun 10, 2016
Aequalis PerFORM+ Shoulder System
K160975 · KWS
Tornier, Inc.
Orthopedic · 64d
Cleared Aug 04, 2015
ForeFoot STP System
K150871 · HWC
Tornier, Inc.
Orthopedic · 125d