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Device Explorer · FDA GUDID · GMDN 44804

Orthopaedic rod reducer

A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scolios

US‑registered devices875in commercial distribution
Companies53labelers on GUDID
Single‑use3%of device records
Sterile3%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.14116%
Globus Medical, Inc.799%
Spineart Sa516%
Alphatec Spine, Inc.455%
Seaspine Orthopedics Corporation435%
Xtant Medical Holdings, Inc.405%
Nuvasive, Inc.394%
Vb Spine Llc384%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.14116%
Globus Medical, Inc.799%
Spineart Sa516%
Alphatec Spine, Inc.455%
Seaspine Orthopedics Corporation435%
Xtant Medical Holdings, Inc.405%
Nuvasive, Inc.394%
Vb Spine Llc384%
Highridge Medical, Llc354%
Synthes Gmbh354%
Cg Medtech Co.,Ltd.314%
Life Spine, Inc.223%

Company = labeler of record on GUDID. 53 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OASYSXia 3XIA ELEGANCEXIA 3XIA 4.5XIAXIA 4.5 EVOLUTIONUNIFLEX Fork PersuaderCarboClear Pedicle Screw System“Paonan” Orthopedic Manual Surgical Instrument (KHEIRONErisma®-LPVital Spinal Fixation SystemPathFinder NXT Minimally Invasive Pedicle Screw Polaris 5.5 Spinal Fixation SystemLineum Occipito-Cervico-Thoracic (OCT) Spinal Fi

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 INSTRUMENT325
LXHOrthopedic manual surgical instrument212
LXHOrthopedic Manual Surgical Instrument100
KWPAppliance, Fixation, Spinal Interlaminal72
NKBThoracolumbosacral Pedicle Screw System70
NKBThoracolumbosacral pedicle screw system56

GMDN & GCC registration

  • GMDN code 44804 · non‑implantable
  • Single‑use 3% · sterile 3% · Rx‑only 77% · 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

Height (Millimeter) · 14Width (Millimeter) · 12Depth (Millimeter) · 9Length (Millimeter) · 2Outer Diameter (Millimeter) · 1Lumen/Inner Diameter (Millimeter) · 1

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

How many orthopaedic rod reducer products are registered in the US?

875 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic rod reducer", from 53 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 16% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), LXH (Orthopedic Manual Surgical Instrument), KWP (Appliance, Fixation, Spinal Interlaminal)

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.

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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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