Data / Medical devices / France / Tornier S.A.S
Tornier S.A.S: FDA-registered device maker in Montbonnot Saint-Martin Isere, France, 15 510(k) clearances
Tornier S.A.S is registered with the FDA (registration 3008388276) in Montbonnot Saint-Martin Isere, France. It lists 6 device types. The FDA files 15 510(k) clearances under its listings, the newest dated February 21, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008388276
- Address
- 176 Rue Lavoisier, Montbonnot Saint-Martin Isere, France, 38330
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- April 22, 2021
- Registered through
- 2027
- Brand names listed
- AEQUALIS REVERSED SHOULDER PROSTHESIS, Aequalis Ascend FLEX Shoulder System, Aequalis Ascend Flex Shoulder System, Aequalis Ascend Flex Titanium Head, Aequalis Reversed II - Threaded Post Baseplate, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Titanium Glenoid Sphere, Aequalis Shoulder System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Shoulder Arthroplasty Implantation System | QHE | 2 | Manufacturer | accessdata.fda.gov |
| Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis | QKW | 2 | Manufacturer | accessdata.fda.gov |
| Shoulder Prosthesis, Reverse Configuration | PHX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 21, 2024 | K232265 | BLUEPRINT Patient Specific Instrumentation | PHX | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| December 16, 2022 | DEN220012 | Tornier Pyrocarbon Humeral Head | QKW | Unknown | Tornier S.A.S. | accessdata.fda.gov |
| November 12, 2021 | K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 12, 2019 | K190521 | Aequalis Ascend Flex Shoulder System | KWS | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| February 22, 2017 | K162800 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| June 10, 2016 | K160555 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| September 24, 2015 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | KWS | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| August 6, 2014 | K140478 | AEQUALIS REVERSED SHOULDER PROSTHESIS | PHX | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| July 18, 2014 | K140082 | AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM | PHX | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| December 5, 2013 | K132285 | AEQUALIS REVERSED SHOULDER PROSTHESIS | PHX | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| January 8, 2013 | K122698 | AEQUALIS ASCEND FLEX SHOULDER SYSTEM | KWS | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| November 3, 2011 | K111902 | AEQUALIS SHOULDER SYSTEM | KWS | Substantially Equivalent | Tornier | accessdata.fda.gov |
| July 17, 2008 | K081059 | AEQUALIS REVERSED SHOULDER PROSTHESIS | PHX | Substantially Equivalent | Tornier | accessdata.fda.gov |
| March 16, 2005 | K050316 | AEQUALIS REVERSED SHOULDER PROSTHESIS | PHX | Substantially Equivalent | Tornier | accessdata.fda.gov |
| May 14, 2004 | K030941 | AEQUALIS REVERSED SHOULDER PROSTHESIS | PHX | Substantially Equivalent | Tornier | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Shoulder Arthroplasty Implantation System
- All makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
Updated February 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.