Consulting Wallah › Device Explorer › Orthopaedic implants › Multiple spinal region orthosis
Device Explorer · FDA GUDID · GMDN 66086

Multiple spinal region orthosis

A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass two or more regions of the spine (e.g., sacroiliac, lumbosacral, thoracolumbosacral) to support or immobilize deformities, fractures, spra

US‑registered devices139in commercial distribution
Companies9labelers on GUDID
Single‑use60%of device records
Sterile0%labelled sterile
Prescription18%Rx‑only share
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Share of device records

Reabilitimed Tov5439%
Trulife Limited3022%
Value&Trust139%
Boston Brace International, Inc.118%
Alimed, Inc.107%
Manamed, Inc.86%
Medical Specialties Incorporated75%
Top Shelf Manufacturing, Llc54%

Top labelers

CompanyDevicesShare
Reabilitimed Tov5439%
Trulife Limited3022%
Value&Trust139%
Boston Brace International, Inc.118%
Alimed, Inc.107%
Manamed, Inc.86%
Medical Specialties Incorporated75%
Top Shelf Manufacturing, Llc54%
Prim S.A.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

"TM ""Rehabilitimed"" L-4M-3V XXXL Comfort""TM ""Rehabilitimed"" L-4M-3V XXL Comfort""TM ""Rehabilitimed"" L-4M-3V XL Comfort""TM ""Rehabilitimed"" L-4M-3V L Comfort""TM ""Rehabilitimed"" L-4M-3V M Comfort""TM ""Rehabilitimed"" L-4M-3V S Comfort""TM ""Rehabilitimed"" L-4M-3 XXXL Comfort""TM ""Rehabilitimed"" L-4M-3 XXL Comfort""TM ""Rehabilitimed"" L-4M-3 XL Comfort""TM ""Rehabilitimed"" L-4M-3 L Comfort""TM ""Rehabilitimed"" L-4M-3 M Comfort""TM ""Rehabilitimed"" L-4M-3 S Comfort""TM ""Rehabilitimed"" L-4M-2 M Comfort""TM ""Rehabilitimed"" L-4M-2 S Comfort""TM ""Rehabilitimed"" L-4M-2 L Comfort""TM ""Rehabilitimed"" L-4M-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
MRIOrthosis, Truncal/Orthosis, Limb42
MRIORTHOSIS, TRUNCAL/ORTHOSIS, LIMB30
IPYOrthosis, Lumbo-Sacral20
QSBOrthosis, Truncal, Pregnancy13
KTDOrthosis, Abdominal13
IQEOrthosis, Lumbar11

GMDN & GCC registration

  • GMDN code 66086 · non‑implantable
  • Single‑use 60% · sterile 0% · Rx‑only 18% · OTC 42%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

No closely related category with 50+ devices.

How many multiple spinal region orthosis products are registered in the US?

139 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple spinal region orthosis", from 9 companies. The largest labeler is Reabilitimed Tov with 39% of records.

Which FDA product codes apply?

MRI (Orthosis, Truncal/Orthosis, Limb), MRI (ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB), IPY (Orthosis, Lumbo-Sacral), QSB (Orthosis, Truncal, Pregnancy)

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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