Consulting Wallah › Device Explorer › Orthoses & supports › Lumbar spine orthosis
Device Explorer · FDA GUDID · GMDN 33031

Lumbar spine orthosis

A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable

US‑registered devices1,220in commercial distribution
Companies31labelers on GUDID
Single‑use40%of device records
Sterile1%labelled sterile
Prescription41%Rx‑only share
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Share of device records

Deroyal Industries, Inc.36830%
Indaco Srl1159%
Bird & Cronin, Llc1079%
Medi Manufacturing, Inc.897%
Neotech Care Inc.847%
Grainger International, Inc.665%
Medical Specialties Incorporated544%
Vive Health Llc494%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.36830%
Indaco Srl1159%
Bird & Cronin, Llc1079%
Medi Manufacturing, Inc.897%
Neotech Care Inc.847%
Grainger International, Inc.665%
Medical Specialties Incorporated544%
Vive Health Llc494%
Reabilitimed Tov484%
Ideavillage Products Corp393%
Jiangxi Weide Rehabilitation Health Management Co., Ltd353%
Pantymed S.A.343%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Lumbar Support BraceTairuibosiBack BracecofoebabakaCofoeM-Brace AirACTIVDAYBEST BACK"TM ""Rehabilitimed"" BR-1 XXL Comfort""TM ""Rehabilitimed"" BR-1 XL Comfort""TM ""Rehabilitimed"" BR-1 L Comfort""TM ""Rehabilitimed"" BR-1 M Comfort""TM ""Rehabilitimed"" BR-1 S Comfort""TM ""Rehabilitimed"" BR-2 XXL Comfort""TM ""Rehabilitimed"" BR-2 XL Comfort"

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

FDA product codes

CodeNameDevices
IQEOrthosis, Lumbar396
IPYORTHOSIS, LUMBO-SACRAL366
IPYOrthosis, Lumbo-Sacral215
IQEORTHOSIS, LUMBAR102
IKXAid, Transfer42
IPXOrthosis, Rib Fracture, Soft34

GMDN & GCC registration

  • GMDN code 33031 · non‑implantable
  • Single‑use 40% · sterile 1% · Rx‑only 41% · OTC 23%
  • 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) · 7Width (Millimeter) · 7

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

No closely related category with 50+ devices.

How many lumbar spine orthosis products are registered in the US?

1,220 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Lumbar spine orthosis", from 31 companies. The largest labeler is Deroyal Industries, Inc. with 30% of records.

Which FDA product codes apply?

IQE (Orthosis, Lumbar), IPY (ORTHOSIS, LUMBO-SACRAL), IPY (Orthosis, Lumbo-Sacral), IQE (ORTHOSIS, LUMBAR)

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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