TORNIER, SAS

FDA Device Registration & Listing · GRENOBLE CEDEX 1 Isere, FR · Registration 3003902387

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003902387
FEI Number
3003902387
Entity Name
TORNIER, SAS
City/State/Country
GRENOBLE CEDEX 1 Isere, FR
Establishment Address
PARC POLYTEC, 20 RUE DES BERGES, GRENOBLE CEDEX 1 Isere 38024, FR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Tornier Flex Shoulder System Tornier Pyrocarbon Humeral Head NEXA CARPOMETACARPAL (CMI) IMPLANT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKW Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis Orthopedic Class 2 888.3695 2023-01-05
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2021-04-23

Official Correspondent

No official correspondent registered.

US Agent Details

Jeanine Redden Email: jeanine.redden@stryker.com Phone: (901) 8674522

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Similar Registrations

Registration Number Establishment Name Location
3000931034 Tornier S.A.S. Montbonnot Saint-Martin Isere, FR
3002807295 IONISOS SABLE-SUR-SARTHE, FR
3008388276 TORNIER S.A.S Montbonnot Saint-Martin Isere, FR
1833506 BIOPRO, INC. PORT HURON, MI, US
1043534 WRIGHT MEDICAL TECHNOLOGY, INC. Arlington, TN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003902387. Last updated year: 2026. Please use registration number 3003902387 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.