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Device Explorer · FDA GUDID · GMDN 47830

Surgical instrument handle, torque-limiting

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst

US‑registered devices1,098in commercial distribution
Companies100labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Tecomet Inc.35332%
Alphatec Spine, Inc.16515%
Vb Spine Llc454%
Highridge Medical, Llc293%
Nuvasive, Inc.272%
Camber Spine Technologies, Llc242%
Cg Medtech Co.,Ltd.212%
Gauthier Biomedical, Inc.202%

Top labelers

CompanyDevicesShare
Tecomet Inc.35332%
Alphatec Spine, Inc.16515%
Vb Spine Llc454%
Highridge Medical, Llc293%
Nuvasive, Inc.272%
Camber Spine Technologies, Llc242%
Cg Medtech Co.,Ltd.212%
Gauthier Biomedical, Inc.202%
Seaspine Orthopedics Corporation192%
Synthes Gmbh182%
Ctl Medical Corporation172%
Xtant Medical Holdings, Inc.172%

Company = labeler of record on GUDID. 100 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PANGEASIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMFASSIER-DUVAL TELESCOPIC IM SYSTEMTandry Orthopedic Manual Surgical InstrumentT-Handle with Torque LimiterLINK Instruments - WrenchesLink Embrace Shoulder System - InstrumentsAlpine XC Adjustable Fusion SystemPathFinder NXT Minimally Invasive Pedicle Screw Polaris 5.5 Spinal Fixation SystemThe Tether Vertebral Body Tethering SystemLineum Occipito-Cervico-Thoracic (OCT) Spinal FiVital MIS Spinal Fixation SystemOptio-C Anterior Cervical SystemST360 Spinal Fixation SystemFlareHawk

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

FDA product codes

CodeNameDevices
HXXScrewdriver355
LXHOrthopedic manual surgical instrument271
LXHOrthopedic Manual Surgical Instrument188
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT143
MAXIntervertebral Fusion Device With Bone Graft, Lumbar20
NKBThoracolumbosacral Pedicle Screw System17

GMDN & GCC registration

  • GMDN code 47830 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 92% · 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

Width (Millimeter) · 4Outer Diameter (Inch) · 2Length (Inch) · 2Pressure (Pound per Square Inch) · 2Outer Diameter (Millimeter) · 1Width (Inch) · 1

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

How many surgical instrument handle, torque-limiting products are registered in the US?

1,098 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical instrument handle, torque-limiting", from 100 companies. The largest labeler is Tecomet Inc. with 32% of records.

Which FDA product codes apply?

HXX (Screwdriver), LXH (Orthopedic manual surgical instrument), LXH (Orthopedic Manual Surgical Instrument), LXH (ORTHOPEDIC MANUAL 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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