Device Explorer · FDA GUDID · GMDN 12099

Knee splint

A rigid, non-articulating, external support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device.

US‑registered devices570in commercial distribution
Companies13labelers on GUDID
Single‑use34%of device records
Sterile0%labelled sterile
Prescription73%Rx‑only share
ShareLinkedIn

Share of device records

Deroyal Industries, Inc.40872%
Darco (Europe) Gmbh417%
Darco International, Inc.346%
Md Orthopaedics, Inc.193%
Djo, Llc163%
Tetra Medical Supply Corp.132%
Vive Health Llc112%
Medical Specialties Incorporated81%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.40872%
Darco (Europe) Gmbh417%
Darco International, Inc.346%
Md Orthopaedics, Inc.193%
Djo, Llc163%
Tetra Medical Supply Corp.132%
Vive Health Llc112%
Medical Specialties Incorporated81%
Manamed, Inc.71%
Elite Orthopaedics, Inc.61%
Tianjin Tairuibosi Medical Appliance Co.,Ltd.41%
Steris Corporation20%

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

Brand names on the register (sample)

TairuibosiPROCARECoreTechVIVEElite Orthopaedics"ManaEZ 3 Panel Knee Immobilizer 16""""ManaEZ 3 Panel Knee Immobilizer 24""""ManaEZ 3 Panel Knee Immobilizer 20""""ManaEZ 3 Panel Knee Immobilizer 18""""ManaEZ Single Panel Knee Immobilizer 24""""ManaEZ Single Panel Knee Immobilizer 20""""ManaEZ Single Panel Knee Immobilizer 18"""RhinoUniversal Foam Knee ImmobilizerDeRoyalNA

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

FDA product codes

CodeNameDevices
ITQJOINT, KNEE, EXTERNAL BRACE498
ITQJoint, Knee, External Brace57
IQIOrthosis, Limb Brace11
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT2
NOCSplint, extremity, non-inflatable, external, non-sterile1
ITCSTIRRUP, EXTERNAL BRACE COMPONENT1

GMDN & GCC registration

  • GMDN code 12099 · non‑implantable
  • Single‑use 34% · sterile 0% · Rx‑only 73% · OTC 9%
  • 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.

How many knee splint products are registered in the US?

570 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Knee splint", from 13 companies. The largest labeler is Deroyal Industries, Inc. with 72% of records.

Which FDA product codes apply?

ITQ (JOINT, KNEE, EXTERNAL BRACE), ITQ (Joint, Knee, External Brace), IQI (Orthosis, Limb Brace), 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.

How do I get quotes?

Add knee splint to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Knee splint

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying knee splint for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →