Consulting Wallah › Device Explorer › Orthopaedic implants › Body-powered elbow prosthesis, locking
Device Explorer · FDA GUDID · GMDN 41097

Body-powered elbow prosthesis, locking

An artificial substitute for a missing elbow used as part of an upper-limb external prosthetic system and designed to restore some of the function of the joint. The device moves as the result of connecting straps/cables or other mechanism powered by the moveme

US‑registered devices83in commercial distribution
Companies1labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Hugh Steeper Limited83100%

Top labelers

CompanyDevicesShare
Hugh Steeper Limited83100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ESPIREControl and Suspension SystemsElbowAutomatic Elbow

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

FDA product codes

CodeNameDevices
IRDJoint, Elbow, External Limb Component, Mechanical83

GMDN & GCC registration

  • GMDN code 41097 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 0% · OTC 0%
  • 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 body-powered elbow prosthesis, locking products are registered in the US?

83 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Body-powered elbow prosthesis, locking", from 1 companies. The largest labeler is Hugh Steeper Limited with 100% of records.

Which FDA product codes apply?

IRD (Joint, Elbow, External Limb Component, Mechanical)

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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