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Device Explorer · FDA GUDID · GMDN 47900

Orthopaedic implant calibration pin

A cylindrical rod used preoperatively as a precision guide to align an orthopaedic implant aiming arm with, e.g., an intramedullary bone nail (femoral, humeral, and tibial) that will be implanted. It is inserted through the guiding locking holes of the adjusta

US‑registered devices150in commercial distribution
Companies10labelers on GUDID
Single‑use36%of device records
Sterile9%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Tornier, Inc.8859%
Smith & Nephew, Inc.1812%
Wright Medical Technology, Inc.117%
Tornier107%
Orthofix Srl107%
Camber Spine Technologies, Llc43%
Adler Ortho Spa43%
Synthes Gmbh32%

Top labelers

CompanyDevicesShare
Tornier, Inc.8859%
Smith & Nephew, Inc.1812%
Wright Medical Technology, Inc.117%
Tornier107%
Orthofix Srl107%
Camber Spine Technologies, Llc43%
Adler Ortho Spa43%
Synthes Gmbh32%
Sontec Instruments, Inc.11%
Medos International Sàrl11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BlueprintAequalis Reversed IITornier PerformNAAequalis Resurfacing HeadACUFEXPRO-DENSEINBONEBIOARCHINFINITYPRECISION BONE GRAFTING SYSTEMTrigenN/AAcufexNo BrandCROSSTRAC

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

FDA product codes

CodeNameDevices
FZXGuide, surgical, instrument67
LXHOrthopedic manual surgical instrument36
NBHACCESSORIES,ARTHROSCOPIC34
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT9
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES8
LXHOrthopedic Manual Surgical Instrument8

GMDN & GCC registration

  • GMDN code 47900 · non‑implantable
  • Single‑use 36% · sterile 9% · 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

Outer Diameter (Millimeter) · 74Length (Millimeter) · 24Length (Inch) · 3Angle (degree) · 1Width (Millimeter) · 1

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

How many orthopaedic implant calibration pin products are registered in the US?

150 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implant calibration pin", from 10 companies. The largest labeler is Tornier, Inc. with 59% of records.

Which FDA product codes apply?

FZX (Guide, surgical, instrument), LXH (Orthopedic manual surgical instrument), NBH (ACCESSORIES,ARTHROSCOPIC), 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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