Device Explorer · FDA GUDID · GMDN 13810

Clavicle orthosis

A prefabricated (non-customized) wearable device intended to be worn over the shoulders of a patient to provide support and protection to a clavicle bone which has been fractured or injured. It incorporates padded straps that loop over each shoulder, under eac

US‑registered devices120in commercial distribution
Companies8labelers on GUDID
Single‑use32%of device records
Sterile0%labelled sterile
Prescription38%Rx‑only share
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Share of device records

Deroyal Industries, Inc.4134%
Pantymed S.A.2622%
Md Orthopaedics, Inc.1916%
Bird & Cronin, Llc1210%
Tianjin Tairuibosi Medical Appliance Co.,Ltd.76%
Vive Health Llc65%
Indaco Srl54%
Reabilitimed Tov43%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.4134%
Pantymed S.A.2622%
Md Orthopaedics, Inc.1916%
Bird & Cronin, Llc1210%
Tianjin Tairuibosi Medical Appliance Co.,Ltd.76%
Vive Health Llc65%
Indaco Srl54%
Reabilitimed Tov43%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TairuibosiM-Brace Air"TM ""Rehabilitimed"" OT-2 XXL Comfort""TM ""Rehabilitimed"" OT-2 UNI Comfort""TM ""Rehabilitimed"" OT-2 UNIp Comfort""TM ""Rehabilitimed"" OT-2 Sp Comfort"Vive HealthVIVERhinoDeRoyalCLAVICLE BRACE W/VELCRO XSCLAVICLE BRACE W/VELCRO XXSCLAVICLE BRACE W/VELCRO XLCLAVICLE BRACE W/VELCRO LGCLAVICLE BRACE W/VELCRO MDCLAVICLE BRACE W/VELCRO SM

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

FDA product codes

CodeNameDevices
IQJSPLINT, CLAVICLE41
IQJSplint, Clavicle35
IPTOrthosis, Thoracic26
IQEOrthosis, Lumbar7
ITQJoint, Knee, External Brace6
NJBOrthosis, Truncal, For Dysmenorrhea5

GMDN & GCC registration

  • GMDN code 13810 · non‑implantable
  • Single‑use 32% · sterile 0% · Rx‑only 38% · OTC 22%
  • 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 clavicle orthosis products are registered in the US?

120 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Clavicle orthosis", from 8 companies. The largest labeler is Deroyal Industries, Inc. with 34% of records.

Which FDA product codes apply?

IQJ (SPLINT, CLAVICLE), IQJ (Splint, Clavicle), IPT (Orthosis, Thoracic), 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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