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Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

by Orthofix, Inc. 53 variants

Ref 99-50-10214

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18054242517313 Basic UDI-DI 18054242517313UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18054242517313 UDI-DI Date25 Apr 2018ListedStatusListed 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-2063-2018 FDA Class II initiated 30 Jan 2018

    The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after September 2016. The firm determined that certain batches of the double row footplates are not compatible with the current version of the TL-HEX struts.

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  • Withdrawn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
Orthofix TrueLok Hexapod System (TL-HEX) V2.0 GUDID
Generic Name
External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog
99-50-10214, 1
Primary DI / UDI-DI
18054242517313
Basic UDI-DI
B-18054242517313
510(k) Number
FDA Product Code
KTT, OSN
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
99-50-10214
GUDID
1
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: External orthopaedic fixation system, single-use

Cleared under the same submission (K170650)

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