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Device Explorer · FDA GUDID · GMDN 60367

Cervical spine immobilization system, single-use

An assembly of orthopaedic devices designed to immobilize the cervical spine (the bones in the neck) after an injury or surgery, to protect the bones from damaging movement during the healing processes. Commonly known as a Halo vest, it typically consists of a

US‑registered devices2,194in commercial distribution
Companies2labelers on GUDID
Single‑use99%of device records
Sterile4%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Pmt Corporation2,193100%
Darby Dental Supply, Llc10%

Top labelers

CompanyDevicesShare
Pmt Corporation2,193100%
Darby Dental Supply, Llc10%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Darby Dental Supply, LLCPMT CORPORATION HALOPMT CORPORATION - STEREOTACTICPMT® Halo SystemsHALO SYSTEM COMPONENTHALO TRAUMA KITHALO RINGPMT® CORPORATION HALOHALO VEST LINER

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

FDA product codes

CodeNameDevices
HAXTong, Skull For Traction2,194
JECCOMPONENT, TRACTION, INVASIVE17
HAXTONG, SKULL FOR TRACTION7
KXRAPPLICATOR, RESIN1
GZLElectrode, Depth1
HWCScrew, fixation, bone1

GMDN & GCC registration

  • GMDN code 60367 · implantable
  • Single‑use 99% · sterile 4% · Rx‑only 100% · 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) · 10Lumen/Inner Diameter (Inch) · 1

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

How many cervical spine immobilization system, single-use products are registered in the US?

2,194 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cervical spine immobilization system, single-use", from 2 companies. The largest labeler is Pmt Corporation with 100% of records.

Which FDA product codes apply?

HAX (Tong, Skull For Traction), JEC (COMPONENT, TRACTION, INVASIVE), HAX (TONG, SKULL FOR TRACTION), KXR (APPLICATOR, RESIN)

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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