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

by Orthofix, Inc. 47 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18033509858215 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

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

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
1, 54-11250
Primary DI / UDI-DI
18033509858215
510(k) Number
FDA Product Code
KTT, OSN
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone pin, non-bioabsorbable

Cleared under the same submission (K170650)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Single Use
  • Implantable
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No