Skip to content

IO Freedom

by Extremity Medical, LLC 2 variants

Ref 147-35815

IO Freedom (147-35815) 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 11 Aug 2026 (Basic UDI-DI B-00842078121436), cleared under FDA 510(k) K201556 on 8 Jul 2020 and listed in FDA GUDID since 9 Sep 2026 (UDI-DI 00842078121436), active as of 22 Oct 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201556

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00842078121436 UDI-DI Date9 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-00842078121436 Basic UDI-DI 00842078121436UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK201556 Date8 Jul 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00842078121436 registered 11 Aug 2026 Active
  • FDA 510(k) K201556 decided 8 Jul 2020 Active
  • FDA GUDID UDI-DI 00842078121436 listed 9 Sep 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201556
  2. Registered EUDAMED B-00842078121436
  3. Listed FDA GUDID 00842078121436

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  • Withdrawn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

Generic name
Implantable bone washer
Device name
FREEDOM X-Post 3.5 x 15mm
Model / reference
147-35815
Primary DI / UDI-DI
00842078121436
Basic UDI-DI
B-00842078121436
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.

Manufacturer details

EUDAMED SRN
US-MF-000018334
Authorised representative
MDSS GmbH DE-AR-000005430

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
  • Manufacturing date
Other properties (17, all answered No)