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Device Explorer · FDA GUDID · GMDN 46511

Surgical traction tensioner

A hand-operated tensioning device designed to be attached to a patient-contact device (e.g., hand wrap/trap, pelvic bone pin, foot boot, skull tongs) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis)

US‑registered devices130in commercial distribution
Companies11labelers on GUDID
Single‑use5%of device records
Sterile1%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Mizuho Corporation5442%
Mizuho Orthopedic Systems, Inc.3023%
Citieffe Srl1814%
Innomed, Inc.1512%
Vilex In Tennessee, Inc.32%
Orthopediatrics Corp.32%
Zimmer, Inc.22%
Mid Central Medical Corp.22%

Top labelers

CompanyDevicesShare
Mizuho Corporation5442%
Mizuho Orthopedic Systems, Inc.3023%
Citieffe Srl1814%
Innomed, Inc.1512%
Vilex In Tennessee, Inc.32%
Orthopediatrics Corp.32%
Zimmer, Inc.22%
Mid Central Medical Corp.22%
Arbutus Medical Inc11%
Vilex Llc11%
Astura Medical11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

V Attachment for Traction DeviceLeg Traction DeviceLeg Traction Device MOC-142Zimmer Persona Knee SystemQuikBowHAND CRANK ASSEMBLYASSEMBLY, TRACTION SPARHAND CRANK, STRAIGHTASSY, TRACTION/LIFTERHAND CRANK, 45 DEGREEDRIVE SHAFT, TRANSVERSE PERINEAL POSTLEG SPAR, LEFTBOWLEG SPAR, RIGHTTRACTION LIFTERLATERAL TRACTION DEVICE

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

FDA product codes

CodeNameDevices
GDCTable, Operating-Room, Electrical54
JEATable, Surgical With Orthopedic Accessories, Ac-Powered33
LXHOrthopedic Manual Surgical Instrument22
KILPositioner, Socket14
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT3
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem2

GMDN & GCC registration

  • GMDN code 46511 · non‑implantable
  • Single‑use 5% · sterile 1% · Rx‑only 64% · 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) · 55Width (Inch) · 2Height (Inch) · 2Length (Inch) · 2Outer Diameter (Millimeter) · 1

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

How many surgical traction tensioner products are registered in the US?

130 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical traction tensioner", from 11 companies. The largest labeler is Mizuho Corporation with 42% of records.

Which FDA product codes apply?

GDC (Table, Operating-Room, Electrical), JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered), LXH (Orthopedic Manual Surgical Instrument), KIL (Positioner, Socket)

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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