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Tornier Humeral Nail 7425048

by Tornier, Inc.

Ref 7425048Model 08858251006888UW

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006888UW Basic UDI-DI 00846832091393UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832091393 UDI-DI Date13 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

2 recalls · FDA

    • Terminated Z-1757-2018 FDA Class II initiated 26 Mar 2018 on shared 510(k) K082754

    Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.

    • Terminated Z-2315-2015 FDA Class II initiated 25 Jun 2015

    Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation will impact alignment and can affect the ability to fixate Aequalis IM Nail screws.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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 Humeral Nail
Generic Name
Orthopaedic bone screw (non-sliding)
Device Name
TORNIER HUMERAL NAIL - PROXIMAL CANNULATED SCREW - Ti6Al4V - CLASS IIB - NON STERILE
Model / Ref / Catalog
7425048, 08858251006888UW
Primary DI / UDI-DI
00846832091393
Basic UDI-DI
08858251006888UW
510(k) Number
FDA Product Code
HSB
EMDN Code
P09120604 Osteosynthesis nail-screw systems
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional
Size
Outer Diameter — 5 Millimeter
Length — 48 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K082754)

Show all (12)

Cleared under the same submission (K230352)

Show all (12)

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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
  • Serial Number: No
  • Expiration Date: No