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True/Lok Monolateral/Bilateral Fixator 1

by Orthofix, Inc. 52 variants

Ref 99-56-12600

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18053340349451 Basic UDI-DI 18053340349451UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18053340349451 UDI-DI Date14 Jun 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-0674-2008 FDA Unclassified (pre-2012) initiated 28 Sep 2007

    Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Truelok System EUDAMED
True/Lok Monolateral/Bilateral Fixator GUDID
Generic Name
External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog
99-56-12600, 1
Primary DI / UDI-DI
18053340349451
Basic UDI-DI
B-18053340349451
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
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
99-56-12600
GUDID
1
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: External orthopaedic fixation system, single-use

Cleared under the same submission (K941048)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No