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Device Explorer · FDA GUDID · GMDN 35788

Orthopaedic bone calliper

A hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusa

US‑registered devices185in commercial distribution
Companies61labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.3619%
Alphatec Spine, Inc.148%
Synthes Gmbh116%
Spineart Sa84%
Life Spine, Inc.74%
Icotec Ag74%
Stryker Corporation42%
Tedan Surgical Innovations, L.L.C.42%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.3619%
Alphatec Spine, Inc.148%
Synthes Gmbh116%
Spineart Sa84%
Life Spine, Inc.74%
Icotec Ag74%
Stryker Corporation42%
Tedan Surgical Innovations, L.L.C.42%
Ctl Medical Corporation42%
Omni Life Science, Inc.42%
Nexus Spine, L.L.C.42%
Cg Medtech Co.,Ltd.42%

Company = labeler of record on GUDID. 61 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NARADIUSREFLEX HYBRIDXIA 4.5XIA IICarboClear X Pedicle Screw SystemCarboClear Cervical SystemsUnity Total Knee SystemUKNEE™VernierHermann Medizintechnik GmbHErisma®-LPVerteFITN/ALEG LENGTH CALIPER ASSYArthrex®

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

FDA product codes

CodeNameDevices
HTJGAUGE, DEPTH39
KTZCALIPER35
LXHOrthopedic Manual Surgical Instrument21
KTZCaliper18
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT17
FTYTAPE, MEASURING, RULERS AND CALIPERS13

GMDN & GCC registration

  • GMDN code 35788 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 78% · 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) · 2Length (Centimeter) · 1

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

How many orthopaedic bone calliper products are registered in the US?

185 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone calliper", from 61 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 19% of records.

Which FDA product codes apply?

HTJ (GAUGE, DEPTH), KTZ (CALIPER), LXH (Orthopedic Manual Surgical Instrument), KTZ (Caliper)

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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