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Device Explorer · FDA GUDID · GMDN 44795

Manual orthopaedic bender, reusable

A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or

US‑registered devices1,924in commercial distribution
Companies133labelers on GUDID
Single‑use5%of device records
Sterile2%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.1659%
Synthes Gmbh1548%
Alphatec Spine, Inc.1367%
Seaspine Orthopedics Corporation1136%
Depuy Spine, Llc1025%
Biomet Orthopedics, Llc573%
Orthopediatrics Corp.563%
Cg Medtech Co.,Ltd.553%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.1659%
Synthes Gmbh1548%
Alphatec Spine, Inc.1367%
Seaspine Orthopedics Corporation1136%
Depuy Spine, Llc1025%
Biomet Orthopedics, Llc573%
Orthopediatrics Corp.563%
Cg Medtech Co.,Ltd.553%
Globus Medical, Inc.523%
Highridge Medical, Llc513%
Vb Spine Llc493%
Jeil Medical Corporation442%

Company = labeler of record on GUDID. 133 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PANGEANAXIA 3XIA ANTERIORRADIUSAVIATOROASYSREFLEX HYBRIDXIA 4.5VARIAXXIA 4.5 EVOLUTIONAXSOSES2 SPINAL SYSTEMPROANCHORAGEPOLARCUP

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

FDA product codes

CodeNameDevices
HXWBENDER793
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT240
HXWBender199
HXPINSTRUMENT, BENDING OR CONTOURING198
LXHOrthopedic manual surgical instrument124
HXPInstrument, Bending Or Contouring95

GMDN & GCC registration

  • GMDN code 44795 · non‑implantable
  • Single‑use 5% · sterile 2% · Rx‑only 86% · 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 (Inch) · 35Length (Centimeter) · 18Outer Diameter (Millimeter) · 13Length (Millimeter) · 3Angle (degree) · 2Width (Centimeter) · 1

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

How many manual orthopaedic bender, reusable products are registered in the US?

1,924 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual orthopaedic bender, reusable", from 133 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 9% of records.

Which FDA product codes apply?

HXW (BENDER), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HXW (Bender), HXP (INSTRUMENT, BENDING OR CONTOURING)

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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