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Tornier Simpliciti® Shoulder System 7122873

by Tornier, Inc.

Ref 7122873Model 08858251006560TR

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006560TR Basic UDI-DI 00846832090464UDI-DIDate7 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832090464 UDI-DI Date25 Apr 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Nov 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Tornier Simpliciti® Shoulder System
Generic Name
Stem-fixed metallic humeral head prosthesis
Device Name
Tornier Simpliciti Shoulder System - Humeral Head - Cobalt Chromium - Class III - Sterile
Model / Ref / Catalog
7122873, 08858251006560TR
Primary DI / UDI-DI
00846832090464
Basic UDI-DI
08858251006560TR
510(k) Number
FDA Product Code
PKC
EMDN Code
P090104010101 Epiphysary humeral components for anatomical prostheses - humeral heads
GMDN Term
Stem-fixed metallic humeral head prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3660
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 50 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Stem-fixed metallic humeral head prosthesis

Cleared under the same submission (K143552)

Show all (12)

Other devices from Tornier, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • CMR Substance
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No