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Device Explorer · FDA GUDID · GMDN 47814

Orthopaedic implantation hammering attachment

A surgical instrument designed to be attached to another surgical implantation instrument or directly to an orthopaedic implant to provide a surface on which an operating surgeon can make strikes, with a surgical hammer or mallet, to insert an orthopaedic impl

US‑registered devices228in commercial distribution
Companies43labelers on GUDID
Single‑use10%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.2511%
Biomet Orthopedics, Llc2411%
Astura Medical198%
Alphatec Spine, Inc.188%
Advanced Orthopaedic Solutions, Inc.136%
Cg Medtech Co.,Ltd.136%
Biomet Uk Ltd125%
Orthofix Srl125%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.2511%
Biomet Orthopedics, Llc2411%
Astura Medical198%
Alphatec Spine, Inc.188%
Advanced Orthopaedic Solutions, Inc.136%
Cg Medtech Co.,Ltd.136%
Biomet Uk Ltd125%
Orthofix Srl125%
Synthes Gmbh115%
Highridge Medical, Llc104%
Integrity Implants Inc.104%
Evolution Spine Llc52%

Company = labeler of record on GUDID. 43 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

KINCISEPiccolo Composite Nailing SystemApexRECAP/MAGNUM INSTRUMENTATIONRECAP/MAGNUM HIP INSTRUMENTATIONEndo-Model Knee System - InstrumentsTRIWAYFlareHawkToro-LFlrehawkLineSiderPhantom Hindfoot TTC/TC Nail SystemDJO SURGICALArthrex®M2a-Magnum™Medtronic Reusable Instruments

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 instrument56
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT49
LXHOrthopedic Manual Surgical Instrument31
HSBRod, Fixation, Intramedullary And Accessories23
MAXIntervertebral Fusion Device With Bone Graft, Lumbar23
KWQAppliance, Fixation, Spinal Intervertebral Body19

GMDN & GCC registration

  • GMDN code 47814 · non‑implantable
  • Single‑use 10% · sterile 0% · Rx‑only 96% · 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

Lumen/Inner Diameter (Millimeter) · 15Outer Diameter (Millimeter) · 4Length (Millimeter) · 3Length (Inch) · 2Width (Millimeter) · 1

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

How many orthopaedic implantation hammering attachment products are registered in the US?

228 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implantation hammering attachment", from 43 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 11% of records.

Which FDA product codes apply?

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