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Device Explorer · FDA GUDID · GMDN 62546

Intraoperative orthopaedic bone pin/screw, single-use

A small rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) and/or implantable device (e.g., fixation plate) to the bone during an orthopaedic surgical procedure; it is not left in situ after the

US‑registered devices316in commercial distribution
Companies17labelers on GUDID
Single‑use88%of device records
Sterile72%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Peter Brasseler Holdings, Llc18358%
Alphatec Spine, Inc.299%
Exactech, Inc.217%
Smith & Nephew, Inc.186%
Captiva Spine, Inc.134%
Integrity Implants Inc.93%
Spineart Sa93%
Folsom Metal Products, Inc.83%

Top labelers

CompanyDevicesShare
Peter Brasseler Holdings, Llc18358%
Alphatec Spine, Inc.299%
Exactech, Inc.217%
Smith & Nephew, Inc.186%
Captiva Spine, Inc.134%
Integrity Implants Inc.93%
Spineart Sa93%
Folsom Metal Products, Inc.83%
Acra-Cut Inc83%
Power Dental U.S.A. Inc.52%
Meditech Spine, Llc31%
Biopro, Inc.31%

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

Brand names on the register (sample)

Brasseler USAPower Dental U.S.A., Inc.Power Dental USAEVOSHarmony12mm Distraction Pin-Double14mm Distraction Pin-Double14mm Distraction Pin12mm Distraction PinTrestleNAGeneral InstrumentsN/ADistraction Screws Caspar typeDistraction Screw Caspar typeIsto Disposable Funnel System Shooter 6mm Cannul

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

FDA product codes

CodeNameDevices
EJLBUR, DENTAL172
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT29
LXHOrthopedic Manual Surgical Instrument24
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES18
LXHOrthopedic manual surgical instrument17
FZXGuide, Surgical, Instrument14

GMDN & GCC registration

  • GMDN code 62546 · non‑implantable
  • Single‑use 88% · sterile 72% · Rx‑only 96% · 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) · 13

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

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

316 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intraoperative orthopaedic bone pin/screw, single-use", from 17 companies. The largest labeler is Peter Brasseler Holdings, Llc with 58% of records.

Which FDA product codes apply?

EJL (BUR, DENTAL), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic Manual Surgical Instrument), HWE (INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES)

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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