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PDS Plates ZX8

by Ethicon Inc.

Ref ZX8Model PDS Polydioxanone Plate

PDS Plates ZX8 is a device classified as Class III in the EU and Class II in the US made by Ethicon Inc., registered in EUDAMED on 14 Nov 2025 (Basic UDI-DI 0705031a007945P) with CE/MDR certificate MDR 730036 valid until 11 Dec 2029, cleared under FDA 510(k) K092590 on 17 Feb 2010 and listed in FDA GUDID since 14 Jun 2017 (UDI-DI 10705031088009), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDR 510(k)

Valid until

11 Dec 2029

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K092590

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705031a007945P Basic UDI-DI 10705031088009UDI-DIDate14 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705031088009 UDI-DI Date14 Jun 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK092590 Date17 Feb 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705031a007945P registered 14 Nov 2025 Active· +1 more in the status table
  • FDA 510(k) K092590 decided 17 Feb 2010 Active
  • FDA GUDID UDI-DI 10705031088009 listed 14 Jun 2017 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 730036 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    4 Feb 2025
    Expires
    11 Dec 2029
    Reason
    Other

Timeline

5 dated events

  1. Cleared FDA 510(k) K092590
  2. Listed FDA GUDID 10705031088009
  3. Certificate issued EUDAMED MDR 730036
  4. Registered EUDAMED 0705031a007945P
  5. Certificate expires EUDAMED MDR 730036

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  • Withdrawn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
Pds EUDAMED
PDS Plates GUDID
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Device name
PDS Polydioxanone Plate violet absorbable
Model / Ref / Catalog
ZX8, PDS Polydioxanone Plate
Primary DI / UDI-DI
10705031088009
Basic UDI-DI
0705031a007945P
510(k) Number
FDA product code
NHB
EMDN code
P900402 Resorbable filling and reconstruction devices
GMDN term
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
874.3620
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Cleared under the same submission (K092590)

Similar devices in this category

Other devices filed under RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)