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Delta Xtend

by DePuy Ireland UC 62 variants

Ref 2307-70-016Model Surgical Instrument Handle, Non-Torque Limiting

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

8 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 Number0603295a004328P Basic UDI-DI 10603295116066UDI-DIDate23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295116066 UDI-DI Date19 Jun 2018ListedStatusListed 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

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0483-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0486-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0489-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0488-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0485-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0490-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0484-2022 FDA Class II initiated 7 Dec 2021
    • Terminated Z-0487-2022 FDA Class II initiated 7 Dec 2021

    Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

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  • Withdrawn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

Generic Name
Surgical instrument handle, non-torque-limiting
Device Name
Surgical Instrument Handle, Non-Torque Limiting
Model / Ref / Catalog
Surgical Instrument Handle, Non-Torque Limiting, 2307-70-016, 230770016
Primary DI / UDI-DI
10603295116066
Basic UDI-DI
0603295a004328P
Direct Marketing DI
10603295116066
510(k) Number
FDA Product Code
PHX, KWS, HSD
EMDN Code
L091104 Orthopaedic prostheses positioners, reusable
GMDN Term
Surgical instrument handle, non-torque-limiting
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3660, 888.3690
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Related devices

Category: Orthopaedic implant impactor, reusable

Other devices from DePuy Ireland UC

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Properties

  • Reusable
  • CMR Substance
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No