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Device Explorer · FDA GUDID · GMDN 47870

Orthopaedic fixation implant alignment tool

A surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for pos

US‑registered devices1,346in commercial distribution
Companies78labelers on GUDID
Single‑use10%of device records
Sterile1%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.13810%
Smith & Nephew, Inc.1028%
Seaspine Orthopedics Corporation806%
United Orthopedic Corp.735%
Life Spine, Inc.715%
Alphatec Spine, Inc.635%
Biomet Orthopedics, Llc584%
Ulrich Medical Usa, Inc.554%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.13810%
Smith & Nephew, Inc.1028%
Seaspine Orthopedics Corporation806%
United Orthopedic Corp.735%
Life Spine, Inc.715%
Alphatec Spine, Inc.635%
Biomet Orthopedics, Llc584%
Ulrich Medical Usa, Inc.554%
Depuy Spine, Llc514%
Implantcast Gmbh453%
Omni Life Science, Inc.453%
Paragon 28, Inc.423%

Company = labeler of record on GUDID. 78 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PANGEAXia 3AVIATOROASYSXIA 3XIA ANTERIORINSTRUMENTCarboClear Posterior Cervical Screw SystemCarboClear Hybrid Pedicle Screw SystemCarboClear X Pedicle Screw SystemTowers Alignment ToolRight Alignment Gauge Superior Crossbars MediumLeft Alignment Gauge Superior Crossbars MediumAlignment Gauge handle MediumAlignment Gauge handle LongRight Alignment Gauge Superior Crossbars Long

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT347
LXHOrthopedic manual surgical instrument207
LXHOrthopedic Manual Surgical Instrument195
FZXGuide, surgical, instrument129
ODPIntervertebral Fusion Device With Bone Graft, Cervical61
NKBThoracolumbosacral pedicle screw system61

GMDN & GCC registration

  • GMDN code 47870 · non‑implantable
  • Single‑use 10% · sterile 1% · Rx‑only 85% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 42Height (Millimeter) · 40Outer Diameter (Millimeter) · 21Guidewire Diameter (Millimeter) · 7Angle (degree) · 6Width (Millimeter) · 4

Use these as the dimensions to specify in a tender line.

How many orthopaedic fixation implant alignment tool products are registered in the US?

1,346 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic fixation implant alignment tool", from 78 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 10% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), LXH (Orthopedic Manual Surgical Instrument), FZX (Guide, surgical, instrument)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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