Tornier, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000025261 FEI 3000718467
Tornier, Inc. is a medical device manufacturer based in the United States, with 8,380 devices listed as of 14 Nov 2026.
- Devices
- 8,380
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 2,984
- EUDAMED 1,129
- FDA 510(k) 1
- Device classes
- FDA Class I 1,632
- FDA Class II 1,352
- EU Class IIb 15
- EU Class I 1
- Top EMDN categories
- Sites and related companies
- Stryker European Operations Limited authorised representative
- Identifiers
- EUDAMED SRN US-MF-000025261
- FDA FEI 3000718467
- DUNS 968990812
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA establishment
- Authorised rep.
- Stryker European Operations LimitedIE
What Tornier, Inc. makes
Tornier, Inc. manufactures orthopaedic devices including non-sliding bone screws, reusable surgical implant templates, and total reverse shoulder prostheses. Their portfolio covers metallic and polyethylene components for shoulder replacements, such as stem-fixed humeral heads, reverse shoulder cups, and coated humeral stems. The company also produces reusable orthopaedic tools like bone-reaming instruments and positioning guides for prosthesis implantation.
The company’s devices are classified under FDA regulations as Class I and Class II, with listings in the FDA’s Unique Device Identifier (UDI) database. Products are designed for orthopaedic applications and comply with relevant US regulatory requirements. The manufacturer operates from the United States.
Catalogue
Search and filter all 8,380 devicesShowing 1-50 of 8,380
Company details
- EUDAMED SRN
- US-MF-000025261
- FDA FEI number
- 3000718467
- DUNS number
- 968990812
- EUDAMED status
- Active
- EUDAMED registered name
- Tornier, Inc.
- Registered address
- 10801, Nesbitt Avenue South, 55437, Minnesota, United States
- Website
- www.stryker.com
- Phone
- +1-6124715641
- PRRC contact
- Jeanine Redden
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 3 Jan 2027
BSI Group The Netherlands B.V. 2797 2 certificates
- MDR 730968 Active
Technical documentation EU MDR
- Issued
- 4 Nov 2025
- Expires
- 28 Nov 2028
- Reason
- Mnf data change
- MDR 734563 Expiring
Technical documentation EU MDR
- Issued
- 29 Aug 2024
- Expires
- 3 Jan 2027
- Reason
- Mnf data change
FDA establishments
- Tornier SAS FR
Frequently asked questions
How many devices does TORNIER, INC. have in the registry?
The registry currently lists 8380 devices for TORNIER, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list TORNIER, INC.'s devices?
Among its 50 most recently registered devices, TORNIER, INC. has devices listed in EUDAMED (28 devices) and FDA GUDID (24 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do TORNIER, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for TORNIER, INC.'s devices are Class I, Class IIa, Class IIb, Class II and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for TORNIER, INC.?
EUDAMED lists 2 certificates for TORNIER, INC. (technical documentation) under MDR. The most recent was issued on 4 Nov 2025.
What are the newest devices from TORNIER, INC. in the registry?
The most recently registered devices listed for TORNIER, INC. include Tornier Simpliciti® Shoulder System, Latitude™ - Elbow, Tornier Perform® Reversed Glenoid and Made-To-Order 9027479.
Which FDA establishments are linked to TORNIER, INC.?
1 FDA establishment is linked to TORNIER, INC. in the registry; they are listed on the company page.