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TrueLok Evo 1

by Orthofix, Inc. 40 variants

Ref 99-882200

TrueLok Evo 1 (99-882200) is a device classified as Class I in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-18052469471906), cleared under FDA 510(k) K212044 on 5 Nov 2021 and listed in FDA GUDID since 28 Dec 2021 (UDI-DI 18052469471906), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212044

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18052469471906 Basic UDI-DI 18052469471906UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18052469471906 UDI-DI Date28 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212044 Date5 Nov 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-18052469471906 registered 7 Oct 2026 Active
  • FDA 510(k) K212044 decided 5 Nov 2021 Active
  • FDA GUDID UDI-DI 18052469471906 listed 28 Dec 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212044
  2. Listed FDA GUDID 18052469471906
  3. Registered EUDAMED B-18052469471906

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  • Withdrawn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
TrueLok Evo
Generic name
External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog
99-882200, 1
Primary DI / UDI-DI
18052469471906
Basic UDI-DI
B-18052469471906
510(k) Number
FDA product code
LXT
EMDN code
P0912040101 Radial bone fixation systems
GMDN term
External orthopaedic fixation system noninvasive component, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
99-882200
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: External orthopaedic fixation system, single-use

Cleared under the same submission (K212044)

and 8 more cleared under K212044

Similar devices in this category

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

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)