Consulting Wallah › Device Explorer › Orthopaedic implants › Intraoperative bone pin/screw, non-sterile
Device Explorer · FDA GUDID · GMDN 62547

Intraoperative bone pin/screw, non-sterile

A small non-sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partiall

US‑registered devices126in commercial distribution
Companies17labelers on GUDID
Single‑use51%of device records
Sterile29%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Exactech, Inc.5745%
Genesys Orthopedics Systems Llc1713%
Cg Medtech Co.,Ltd.108%
Spineart Sa86%
Adin Dental Implant Systems Ltd54%
Surgalign Spine Technologies, Inc.54%
Biopro, Inc.43%
Crossroads Extremity Systems32%

Top labelers

CompanyDevicesShare
Exactech, Inc.5745%
Genesys Orthopedics Systems Llc1713%
Cg Medtech Co.,Ltd.108%
Spineart Sa86%
Adin Dental Implant Systems Ltd54%
Surgalign Spine Technologies, Inc.54%
Biopro, Inc.43%
Crossroads Extremity Systems32%
Engage Uni Llc32%
Pantheon Spinal, Llc32%
Kalitec Direct Llc32%
Smith & Nephew, Inc.22%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Guided Vertical fixation screw S-5.5Guided Vertical fixation screw S-3.32.0D 19mmL Anchorage Screw2.0D 13mmL Anchorage Screw2.0D 15mmL Anchorage ScrewENGAGEHolding PinAccu-JointHOLO PortalTriMAX Implant SystemADVANCE®SIGMAEngage Partial Knee SystemOrion Sacroiliac Joint Fusion SystemCURE ACPMATIRA ANTERIOR CERVICAL SYSTEM

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

FDA product codes

CodeNameDevices
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES29
LXHOrthopedic manual surgical instrument28
OURSacroiliac Joint Fixation20
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT11
OVEIntervertebral Fusion Device With Integrated Fixation, Cervi8
LXHOrthopedic Manual Surgical Instrument6

GMDN & GCC registration

  • GMDN code 62547 · non‑implantable
  • Single‑use 51% · sterile 29% · Rx‑only 97% · 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) · 23Length (Inch) · 23Outer Diameter (Millimeter) · 10Length (Centimeter) · 2Height (Millimeter) · 1

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

How many intraoperative bone pin/screw, non-sterile products are registered in the US?

126 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intraoperative bone pin/screw, non-sterile", from 17 companies. The largest labeler is Exactech, Inc. with 45% of records.

Which FDA product codes apply?

HWE (INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES), LXH (Orthopedic manual surgical instrument), OUR (Sacroiliac Joint Fixation), 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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