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5983-16

by Zimmer, Inc.

Ref 00-5983-016-00

5983-16 (00-5983-016-00) is a Class I device made by Zimmer, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 889024-ZB004449-H5) and listed in FDA GUDID since 9 Jun 2016 (UDI-DI 00889024218024), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024-ZB004449-H5 Basic UDI-DI 00889024218024UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024218024 UDI-DI Date9 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB004449-H5 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00889024218024 listed 9 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024218024
  2. Registered EUDAMED 889024-ZB004449-H5

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  • Withdrawn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
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
KN NexGen MIS Tib Depth Resection Stylus
Model / Ref / Catalog
00-5983-016-00, 5983-16
Primary DI / UDI-DI
00889024218024
Basic UDI-DI
889024-ZB004449-H5
FDA product code
LXH
EMDN code
L090999 Orthopaedic surgery cutting instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00-5983-016-00
GUDID
5983-16

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)