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CompressX 101-45026-2

by Extremity Medical, LLC

Ref 101-45026-2

CompressX 101-45026-2 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 22 Oct 2026 (Basic UDI-DI B-00842078100844), cleared under FDA 510(k) K081934 on 29 Aug 2008 and listed in FDA GUDID since 27 Jun 2019 (UDI-DI 00842078100844), 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) K081934

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-00842078100844 Basic UDI-DI 00842078100844UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842078100844 UDI-DI Date27 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK081934 Date29 Aug 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00842078100844 registered 22 Oct 2026 Active
  • FDA 510(k) K081934 decided 29 Aug 2008 Active
  • FDA GUDID UDI-DI 00842078100844 listed 27 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K081934
  2. Listed FDA GUDID 00842078100844
  3. Registered EUDAMED B-00842078100844

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  • Withdrawn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
CompressX2 EUDAMED
CompressX GUDID
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device name
Compression Screw - 4.5mm x 26mm
Model / reference
101-45026-2
Primary DI / UDI-DI
00842078100844
Basic UDI-DI
B-00842078100844
510(k) Number
FDA product code
HWC
EMDN code
P09120603 Cannulated screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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-bioabsorbable, non-sterile

Cleared under the same submission (K081934)

and 8 more cleared under K081934

Similar devices in this category

Other devices filed under CANNULATED SCREWS.

Other devices from Extremity Medical, LLC

See all devices from Extremity Medical, LLC →

Properties

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