Device Desk

Private service · Not FDA

FDA device establishment · Lewisville, TX

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-2183449As of September 30, 2026

ORTHOFIX US LLC

Registration 2183449FEI 2183449Lewisville, TX

Owner/operator: Orthofix US LLC

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
328
Added, last 12 months
52

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 328

CodeDeviceClassRegulationPremarket
MJOM6-C Artificial Cervical DiscProsthesis, Intervertebral DiscClass 3—P170036
KTTTrueLok EvoAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Nov 20, 2025Class 221 CFR 888.3030K212044
KTTTrueLok Hexapod System (TL-HEX) V2Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Nov 20, 2025Class 221 CFR 888.3030K170650
KTTTrueLok ElevateAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Nov 20, 2025Class 221 CFR 888.3030K242861
KTTGalaxy wristAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Nov 20, 2025Class 221 CFR 888.3030K141760
KTTGALAXY UNYCO DIAPHYSEAL TIBIA KITAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Nov 20, 2025Class 221 CFR 888.3030K142052
KTTGalaxy Fixation SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Nov 20, 2025Class 221 CFR 888.3030K113770
KTTGalaxy UNYCO SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Nov 20, 2025Class 221 CFR 888.3030K170146
KTTGalaxy UNYCO SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Nov 20, 2025Class 221 CFR 888.3030K153233
LXTTrueLok EvoAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeAdded Nov 20, 2025Class 221 CFR 888.3030K212044
LXTTRUE/LOK MONOLATERAL/BILATERAL FIXATORAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass 221 CFR 888.3030K941048
KTWCONTOURS Proximal humeral plateAppliance, Fixation, Nail/Blade/Plate Combination, Single ComponentAdded Nov 20, 2025Class 221 CFR 888.3030K122541

and 316 more on your full dossier

What changed

  • Nov 20, 2025Listing added: KTT — TrueLok Evo (K212044)
  • Nov 20, 2025Listing added: KTT — TrueLok Hexapod System (TL-HEX) V2 (K170650)
  • Nov 20, 2025Listing added: KTT — TrueLok Elevate (K242861)
  • Nov 20, 2025Listing added: KTT — Galaxy wrist (K141760)
  • Nov 20, 2025Listing added: KTT — GALAXY UNYCO DIAPHYSEAL TIBIA KIT (K142052)
  • Nov 20, 2025Listing added: KTT — Galaxy Fixation System (K113770)
  • Nov 20, 2025Listing added: KTT — Galaxy UNYCO System (K170146)
  • Nov 20, 2025Listing added: KTT — Galaxy UNYCO System (K153233)
  • Nov 20, 2025Listing added: LXT — TrueLok Evo (K212044)
  • Nov 20, 2025Listing added: KTW — CONTOURS Proximal humeral plate (K122541)
  • Nov 20, 2025Listing added: KTW — Titanium humeral plating system LSP (K062920)
  • Nov 20, 2025Listing added: JDO — GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM (K983814)
  • Nov 20, 2025Listing added: JDX — Oscar 2 (K961725)
  • Nov 20, 2025Listing added: JDX — Oscar 3 (K093805)
  • Nov 20, 2025Listing added: QLQ — M6-C™ Single Use, Disposable Instrumentation (K241117)
  • Nov 20, 2025Listing added: QLQ — M6-C Artificial Cervical Disc Instruments AS (K220861)
  • Nov 20, 2025Listing added: JDS — Titanium Nailing System (K053261)
  • Nov 19, 2025Listing added: OLO — Firebird SI Navigation System (K252088)
  • Nov 20, 2025Listing added: HTY — MJ-FLEX THE NEW METAIZEAU NAIL (K173051)
  • Nov 20, 2025Listing added: JDW — EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING (K974186)
  • Nov 20, 2025Listing added: OBT — Guided Growth Plate System Plus (K180624)
  • Nov 20, 2025Listing added: OBT — Guided Growth Plate System Plus (K172183)
  • Nov 20, 2025Listing added: HRS — SOLE Medial Column Fusion Plate (K210157)
  • Nov 20, 2025Listing added: HRS — JPS JuniOrtho Plating System (K200246)
  • Nov 20, 2025Listing added: HRS — RIVAL View Plating Systems and Reduce Fracture Plating Systems (K190388)
  • Nov 20, 2025Listing added: HRS — REDUCE FRACTURE PLATING SYSTEM (K142135)
  • Nov 20, 2025Listing added: HRS — VIEW and REDUCE plating system (K140876)
  • Nov 20, 2025Listing added: HRS — MIOT plating system (K051945)
  • Nov 20, 2025Listing added: HSB — FitboneTM Trochanteric (K250112)
  • Nov 20, 2025Listing added: HSB — Titanium Nailing System (K053261)
  • Nov 20, 2025Listing added: HSB — Fitbone Trochanteric (K233867)
  • Nov 20, 2025Listing added: HSB — TIBIAL NAILING SYSTEM (K961027)
  • Nov 20, 2025Listing added: HSB — RODEO Telescopic Nail (K232648)
  • Nov 20, 2025Listing added: HSB — CHIMAERA Hip Fracture System - Trochanteric Nailing System (K161466)
  • Nov 20, 2025Listing added: HSB — Agile Nail (K172699)
  • Nov 20, 2025Listing added: HSB — FITBONE® Transport and Lengthening System (K232169)
  • Nov 20, 2025Listing added: HSB — ankle hindfoot nailing system (K141571)
  • Nov 20, 2025Listing added: HSB — FITBONE TAA (K163368)
  • Nov 20, 2025Listing added: HSB — FITBONE(R) TAA (K203399)
  • Nov 20, 2025Listing added: HSB — FEMORAL NAILING SYTEM (K973944)
  • Nov 20, 2025Listing added: HWC — JuniOrtho Plating System (K213572)
  • Nov 20, 2025Listing added: HWC — BITE compression screw (K132893)
  • Nov 20, 2025Listing added: HWC — MJ-FLEX THE NEW METAIZEAU NAIL (K173051)
  • Nov 20, 2025Listing added: HWC — SOLE Medial Column Fusion Plate (K210157)
  • Nov 20, 2025Listing added: HWC — G-Beam Fusion Beaming System (K172698)
  • Nov 20, 2025Listing added: HWC — VIEW and REDUCE plating system (K140876)
  • Nov 20, 2025Listing added: HWC — JPS JuniOrtho Plating System (K200246)
  • Nov 20, 2025Listing added: HWC — RIVAL View Plating Systems and Reduce Fracture Plating Systems (K190388)
  • Nov 20, 2025Listing added: OSN — TrueLok Hexapod System (TL-HEX) V2 (K170650)
  • Nov 20, 2025Listing added: GDW — BIOTRONIK torque wrench (K163523)
  • Nov 20, 2025Listing added: LZV — Oscar 3 (K093805)
  • Nov 20, 2025Listing added: LLZ — KAWE stethoscope (K163421)
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

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Keep this desk: $249 a year

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