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47-2358-001-04

by Zimmer, Inc.

Ref 47-2358-001-04

47-2358-001-04 is a device classified as Class IIb in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024-ZB001060-EP), cleared under FDA 510(k) K111039 on 19 May 2011 (1 earlier submission) and listed in FDA GUDID since 28 Sep 2017 (UDI-DI 00889024088733), active as of 7 Nov 2026. 4 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111039

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024-ZB001060-EP Basic UDI-DI 00889024088733UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024088733 UDI-DI Date28 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK111039 Date19 May 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB001060-EP registered 30 Oct 2026 Active
  • FDA 510(k) K111039 decided 19 May 2011 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00889024088733 listed 28 Sep 2017 Listed

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0316-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0311-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0309-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0310-2020 FDA Class II initiated 10 Oct 2019

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Timeline

8 dated events

  1. Cleared FDA 510(k) K043227
  2. Cleared FDA 510(k) K111039
  3. Listed FDA GUDID 00889024088733
  4. Recall initiated FDA recalls Z-0316-2020
  5. Recall initiated FDA recalls Z-0311-2020
  6. Recall initiated FDA recalls Z-0309-2020
  7. Recall initiated FDA recalls Z-0310-2020
  8. Registered EUDAMED 889024-ZB001060-EP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Zimmer® Periarticular Locking Plate System
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
ZPLP Plate Humoral Proximal Lateral Right Sterile
Model / Ref / Catalog
47-2358-001-04
Primary DI / UDI-DI
00889024088733
Basic UDI-DI
889024-ZB001060-EP
510(k) Number
FDA product code
HRS, HWC
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030, 888.3040
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 90 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K043227)

and 7 more cleared under K043227

Cleared under the same submission (K111039)

and 8 more cleared under K111039

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)