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Axis 130-55920

by Extremity Medical, LLC

Ref 130-55920

Axis 130-55920 is an implantable bone washer (EU MDD Class IIb; FDA Class II; FDA product code HTN, Washer, Bolt Nut) made by Extremity Medical, LLC, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-00842078113103), cleared under FDA 510(k) K171018 on 13 Jul 2017 and listed in FDA GUDID since 26 Jun 2019 (UDI-DI 00842078113103), 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-00842078113103 Basic UDI-DI 00842078113103UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842078113103 UDI-DI Date26 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-00842078113103 registered 28 Oct 2026 Active
  • FDA 510(k) K171018 decided 13 Jul 2017 Active
  • FDA GUDID UDI-DI 00842078113103 listed 26 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171018
  2. Listed FDA GUDID 00842078113103
  3. Registered EUDAMED B-00842078113103

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  • Withdrawn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
Implantable bone washer
Device name
Compression Clip, 5.5 x 20 mm
Model / reference
130-55920
Primary DI / UDI-DI
00842078113103
Basic UDI-DI
B-00842078113103
510(k) Number
FDA product code
HTN
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Implantable bone washer
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
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: Implantable bone washer

Cleared under the same submission (K171018)

and 8 more cleared under K171018

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

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)