Consulting Wallah › Device Explorer › Other devices › Cervical spine collar, single-use
Device Explorer · FDA GUDID · GMDN 45129

Cervical spine collar, single-use

A prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This devi

US‑registered devices919in commercial distribution
Companies12labelers on GUDID
Single‑use64%of device records
Sterile0%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Deroyal Industries, Inc.55861%
Pmt Corporation19121%
Bird & Cronin, Llc738%
Reabilitimed Tov273%
Breg, Inc.263%
Ambu A/S233%
Spencer Italia Srl71%
Medsource International Llc40%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.55861%
Pmt Corporation19121%
Bird & Cronin, Llc738%
Reabilitimed Tov273%
Breg, Inc.263%
Ambu A/S233%
Spencer Italia Srl71%
Medsource International Llc40%
Md Orthopaedics, Inc.40%
Trulife Limited30%
Tetra Medical Supply Corp.20%
Xiamen Compower Medical Tech. Co., Ltd10%

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

Brand names on the register (sample)

Lightning X Products, Inccuraplex®Ambu® Redi-ACEAmbu® Immobilization Kit, withAmbu® Mini Perfit ACE™Ambu® Military Perfit ACE™Ambu® Perfit ACE™Ambu® Perfit Collar™"TM ""Rehabilitimed"" ORTEZ-2V XL-110 Comfort""TM ""Rehabilitimed"" ORTEZ-2V L-110 Comfort""TM ""Rehabilitimed"" ORTEZ-2V M-110 Comfort""TM ""Rehabilitimed"" ORTEZ-2V XL-90 Comfort""TM ""Rehabilitimed"" ORTEZ-2V L-90 Comfort""TM ""Rehabilitimed"" ORTEZ-2V M-90 Comfort""TM ""Rehabilitimed"" ORTEZ-2V XL-75 Comfort""TM ""Rehabilitimed"" ORTEZ-2V L-75 Comfort"

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

FDA product codes

CodeNameDevices
IQKOrthosis, cervical582
IQKOrthosis, Cervical328
IQFOrthosis, Cervical-Thoracic, Rigid6
IQJSplint, Clavicle4
IQFORTHOSIS, CERVICAL-THORACIC, RIGID4
CCXSupport, Patient Position2

GMDN & GCC registration

  • GMDN code 45129 · non‑implantable
  • Single‑use 64% · sterile 0% · Rx‑only 87% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Gram) · 2Height (Millimeter) · 2Length (Millimeter) · 2Width (Millimeter) · 2

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

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

919 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cervical spine collar, single-use", from 12 companies. The largest labeler is Deroyal Industries, Inc. with 61% of records.

Which FDA product codes apply?

IQK (Orthosis, cervical), IQK (Orthosis, Cervical), IQF (Orthosis, Cervical-Thoracic, Rigid), IQJ (Splint, Clavicle)

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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