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Axis 130-45065

by Extremity Medical, LLC

Ref 130-45065

Axis 130-45065 is a device classified as Class IIb in the EU and Class II in the US made by Extremity Medical, LLC, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-00842078112649), cleared under FDA 510(k) K171018 on 13 Jul 2017 and listed in FDA GUDID since 24 Jun 2019 (UDI-DI 00842078112649), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171018

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00842078112649 Basic UDI-DI 00842078112649UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842078112649 UDI-DI Date24 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171018 Date13 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00842078112649 registered 26 Oct 2026 Active
  • FDA 510(k) K171018 decided 13 Jul 2017 Active
  • FDA GUDID UDI-DI 00842078112649 listed 24 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171018
  2. Listed FDA GUDID 00842078112649
  3. Registered EUDAMED B-00842078112649

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Axis Beaming EUDAMED
Axis GUDID
Generic name
Orthopaedic bone screw (non-sliding)
Device name
Midfoot Beam, 4.5 x 65 mm
Model / reference
130-45065
Primary DI / UDI-DI
00842078112649
Basic UDI-DI
B-00842078112649
510(k) Number
FDA product code
HWC
EMDN code
P09120603 Cannulated screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K171018)

and 8 more cleared under K171018

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS.

Other devices from Extremity Medical, LLC

See all devices from Extremity Medical, LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (18, all answered No)