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Device Explorer · FDA GUDID · GMDN 34827

Tendon/ligament tunneller

A long, hand-held, manual surgical instrument designed to tunnel an artificial passageway along ligament and/or tendon tissue to create a connecting channel. It can have a variety of designs: 1) a long, round, stiff rod that tapers to a rounded point at the di

US‑registered devices63in commercial distribution
Companies13labelers on GUDID
Single‑use6%of device records
Sterile6%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Cg Medtech Co.,Ltd.2032%
Surgical Direct, Inc.1422%
Boss Instruments, Ltd., Inc.46%
Biomet Orthopedics, Llc46%
Steris Corporation46%
Orthopediatrics Corp.35%
Bausch & Lomb Incorporated35%
Avalign Technologies, Inc.35%

Top labelers

CompanyDevicesShare
Cg Medtech Co.,Ltd.2032%
Surgical Direct, Inc.1422%
Boss Instruments, Ltd., Inc.46%
Biomet Orthopedics, Llc46%
Steris Corporation46%
Orthopediatrics Corp.35%
Bausch & Lomb Incorporated35%
Avalign Technologies, Inc.35%
St. Jude Medical, Inc.23%
Advanced Neuromodulation Systems, Inc.23%
Novo Surgical, Inc.23%
Innomed, Inc.12%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NABOSS InstrumentsCarpal Tunnel ReleaseNovo SurgicalOrthopediatrics InstrumentationOrthoPediatrics PediFoot Deformity Correction SyInnomed, Inc.Bausch + LombMillenniumAvalignSurgical DirectRESTOREV. MuellerPolarfix™ Facet Screw SystemANAX™ 5.5 SPINAL SYSTEMPERFIX™ MIS

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, instrument21
HTDFORCEPS14
DWPDilator, Vessel, Surgical6
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT6
HAOINSTRUMENT, SURGICAL, NON-POWERED5
HWQPASSER5

GMDN & GCC registration

  • GMDN code 34827 · non‑implantable
  • Single‑use 6% · sterile 6% · Rx‑only 75% · 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 (Inch) · 2

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

How many tendon/ligament tunneller products are registered in the US?

63 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tendon/ligament tunneller", from 13 companies. The largest labeler is Cg Medtech Co.,Ltd. with 32% of records.

Which FDA product codes apply?

FZX (Guide, surgical, instrument), HTD (FORCEPS), DWP (Dilator, Vessel, Surgical), 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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