Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Orthopaedic counter-torque/rod-pushing instrument
Device Explorer · FDA GUDID · GMDN 47554

Orthopaedic counter-torque/rod-pushing instrument

A hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instr

US‑registered devices1,169in commercial distribution
Companies70labelers on GUDID
Single‑use11%of device records
Sterile0%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.23420%
Seaspine Orthopedics Corporation11410%
Alphatec Spine, Inc.958%
Life Spine, Inc.605%
Highridge Medical, Llc504%
Cg Medtech Co.,Ltd.454%
Xtant Medical Holdings, Inc.403%
Synthes Gmbh393%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.23420%
Seaspine Orthopedics Corporation11410%
Alphatec Spine, Inc.958%
Life Spine, Inc.605%
Highridge Medical, Llc504%
Cg Medtech Co.,Ltd.454%
Xtant Medical Holdings, Inc.403%
Synthes Gmbh393%
Ctl Medical Corporation343%
Bk Meditech Co.,Ltd.282%
Nuvasive, Inc.242%
Zavation Llc222%

Company = labeler of record on GUDID. 70 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RADIUSTRIOOASYSXIA 3THOR Anterior Plating SystemDIAPASONXIALITe PEDICLE BASED RETRACTORXIA 4.5 System - XIA CTXIA 4.5 EVOLUTIONES2 SPINAL SYSTEMCarboClear Posterior Cervical Screw SystemCarboClear Hybrid Pedicle Screw SystemCarboClear X Pedicle Screw SystemCounter Torque STCounter Torque with Tight Slots

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 INSTRUMENT349
LXHOrthopedic manual surgical instrument230
LXHOrthopedic Manual Surgical Instrument144
HXCWRENCH99
KWPAppliance, Fixation, Spinal Interlaminal84
NKBThoracolumbosacral Pedicle Screw System81

GMDN & GCC registration

  • GMDN code 47554 · non‑implantable
  • Single‑use 11% · sterile 0% · Rx‑only 87% · 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) · 7

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

How many orthopaedic counter-torque/rod-pushing instrument products are registered in the US?

1,169 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic counter-torque/rod-pushing instrument", from 70 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 20% of records.

Which FDA product codes apply?

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

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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