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Device Explorer · FDA GUDID · GMDN 47904

Orthopaedic bone-reduction tool

A hand-held manual surgical instrument that is fed down the intramedullary canal of a long bone (e.g., the femur) to help reposition a fracture where the two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. It

US‑registered devices74in commercial distribution
Companies20labelers on GUDID
Single‑use7%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Synthes Gmbh1520%
Stryker Gmbh1419%
Advanced Orthopaedic Solutions, Inc.811%
Orthopediatrics Corp.57%
Premia Spine Ltd45%
Smith & Nephew, Inc.45%
Nuvasive Specialized Orthopedics, Inc.45%
Osteocentric Technologies, Inc.34%

Top labelers

CompanyDevicesShare
Synthes Gmbh1520%
Stryker Gmbh1419%
Advanced Orthopaedic Solutions, Inc.811%
Orthopediatrics Corp.57%
Premia Spine Ltd45%
Smith & Nephew, Inc.45%
Nuvasive Specialized Orthopedics, Inc.45%
Osteocentric Technologies, Inc.34%
Trimed, Inc.23%
Fusion Orthopedics, Llc23%
Flower Orthopedics Corporation23%
Orthofix Srl23%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAVARIAXTRIAXQuick Reduction ToolMIS Reduction Tool KnobMIS Reduction Tool Tower ConnectorMIS reduction Tool reducerPiccolo Composite Nailing SystemReduction RodApexGAMMATRIGENTHP™ Hip Fracture Plating SystemTRIGEN MAXREDUCTION TOOL SMALL BONE NAILSAXENA RETRACTOR

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 INSTRUMENT28
LXHOrthopedic Manual Surgical Instrument17
HSBRod, Fixation, Intramedullary And Accessories6
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5
NKBThoracolumbosacral Pedicle Screw System4
MNIOrthosis, Spinal Pedicle Fixation4

GMDN & GCC registration

  • GMDN code 47904 · non‑implantable
  • Single‑use 7% · sterile 0% · Rx‑only 100% · 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) · 2Length (Centimeter) · 1Width (Millimeter) · 1

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

How many orthopaedic bone-reduction tool products are registered in the US?

74 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone-reduction tool", from 20 companies. The largest labeler is Synthes Gmbh with 20% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic Manual Surgical Instrument), HSB (Rod, Fixation, Intramedullary And Accessories), HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES)

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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