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K2M General Instruments AG01-96091

by VB Spine LLC

Ref AG01-96091Model 08858251002152SA

K2M General Instruments AG01-96091 is a Class I device made by VB Spine LLC, registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI 08858251002152SA) and listed in FDA GUDID since 10 Jun 2020 (UDI-DI 10888857468924), 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 Number08858251002152SA Basic UDI-DI 10888857468924UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10888857468924 UDI-DI Date10 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002152SA registered 31 Oct 2026 Active
  • FDA GUDID UDI-DI 10888857468924 listed 10 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10888857468924
  2. Registered EUDAMED 08858251002152SA

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  • Withdrawn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
K2M General Instruments
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Lateral Disc Prep mallet
Model / Ref / Catalog
AG01-96091, 08858251002152SA
Primary DI / UDI-DI
10888857468924
Basic UDI-DI
08858251002152SA
Direct marketing DI
10888857468924
FDA product code
LXH
EMDN code
L0903 Orthopaedic surgery hammers, reusable
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

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY HAMMERS, REUSABLE.

Other devices from VB Spine LLC

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)