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Device Explorer · FDA GUDID · GMDN 66935

Orthopaedic intraoperative positioning pin, single-use

A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as

US‑registered devices935in commercial distribution
Companies45labelers on GUDID
Single‑use93%of device records
Sterile43%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Gebr. Brasseler Gmbh & Co. Kg19321%
Peter Brasseler Holdings, Llc9911%
Smith & Nephew, Inc.9610%
Arthrex, Inc.697%
Treace Medical Concepts, Inc.637%
Novastep485%
Stryker Gmbh455%
Medartis Ag404%

Top labelers

CompanyDevicesShare
Gebr. Brasseler Gmbh & Co. Kg19321%
Peter Brasseler Holdings, Llc9911%
Smith & Nephew, Inc.9610%
Arthrex, Inc.697%
Treace Medical Concepts, Inc.637%
Novastep485%
Stryker Gmbh455%
Medartis Ag404%
Orthopediatrics Corp.394%
Enztec Limited354%
Trimed, Inc.263%
Vb Spine Llc192%

Company = labeler of record on GUDID. 45 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAVARIAXREUNIONPROAXSOST2HOFFMANNAsnisGAMMAPiccolo Composite Plate SystemCarboClear X Pedicle Screw SystemPiccolo Composite Nailing SystemPro-X1ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOrthoSolutions 'System26' Bone ScrewsVolition™ Plating System

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

FDA product codes

CodeNameDevices
HWCScrew, Fixation, Bone182
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces133
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT80
LXHOrthopedic Manual Surgical Instrument79
HTYPin, Fixation, Smooth74
LXHOrthopedic manual surgical instrument60

GMDN & GCC registration

  • GMDN code 66935 · non‑implantable
  • Single‑use 93% · sterile 43% · 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

Length (Millimeter) · 95Outer Diameter (Millimeter) · 33Length (Inch) · 3Angle (degree) · 2

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

How many orthopaedic intraoperative positioning pin, single-use products are registered in the US?

935 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic intraoperative positioning pin, single-use", from 45 companies. The largest labeler is Gebr. Brasseler Gmbh & Co. Kg with 21% of records.

Which FDA product codes apply?

HWC (Screw, Fixation, Bone), HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Acces), 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.

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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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