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Spline Implant System 1537

by ZimVie US Corp LLC

Part of a family of 22 devices: see the family page

Ref 1537

Spline Implant System 1537 is a device classified as Class IIb in the EU and Class II in the US made by ZimVie US Corp LLC, registered in EUDAMED on 30 Jul 2026 (Basic UDI-DI 844868BFJ5) and listed in FDA GUDID since 23 Oct 2015 (UDI-DI 00889024011885), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868BFJ5 Basic UDI-DI 00889024011885UDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024011885 UDI-DI Date23 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868BFJ5 registered 30 Jul 2026 Active
  • FDA GUDID UDI-DI 00889024011885 listed 23 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024011885
  2. Registered EUDAMED 844868BFJ5

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  • Withdrawn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
Spline® EUDAMED
Spline Implant System GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Retaining Screws
Model / reference
1537
Primary DI / UDI-DI
00889024011885
Basic UDI-DI
844868BFJ5
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Dental implant suprastructure, permanent, preformed

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)