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Device Explorer · FDA GUDID · GMDN 47858

Surgical instrument torque limiter

A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e

US‑registered devices110in commercial distribution
Companies31labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Silony Medical Gmbh1715%
I.T.S. Gmbh1413%
Synthes Gmbh1312%
Stryker Gmbh76%
Carbofix Orthopedics Ltd65%
Aap Implantate Ag55%
Medtronic Sofamor Danek, Inc.55%
Jeil Medical Corporation55%

Top labelers

CompanyDevicesShare
Silony Medical Gmbh1715%
I.T.S. Gmbh1413%
Synthes Gmbh1312%
Stryker Gmbh76%
Carbofix Orthopedics Ltd65%
Aap Implantate Ag55%
Medtronic Sofamor Danek, Inc.55%
Jeil Medical Corporation55%
Premia Spine Ltd44%
Miami Device Solutions Llc33%
Osteonic Co.,Ltd.33%
Double Medical Technology Inc.22%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PANGEAAXSOSCarboClear Posterior Cervical Screw SystemCarboClear X Pedicle Screw SystemVersalink Torque LimiterScrewdriver with Torque Limiter (Torx)Torque LimiterVersaLink Torque LimiterCarboClear Pedicle Screw SystemPiccolo Composite Plate SystemTorque Limiter, 0.8 N-mTorque Limiter 0.4 N-mUSTAR II Knee SystemMUTARS® torque wrench M8 M10NAMobileLink Acetabular Cup System - 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 instrument24
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT17
LRZScrewdriver, Surgical14
NKBThoracolumbosacral Pedicle Screw System8
HRSPlate, Fixation, Bone8
LXHOrthopedic Manual Surgical Instrument8

GMDN & GCC registration

  • GMDN code 47858 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 68% · 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) · 2

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

How many surgical instrument torque limiter products are registered in the US?

110 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical instrument torque limiter", from 31 companies. The largest labeler is Silony Medical Gmbh with 15% of records.

Which FDA product codes apply?

LXH (Orthopedic manual surgical instrument), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LRZ (Screwdriver, Surgical), NKB (Thoracolumbosacral Pedicle Screw System)

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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