Consulting Wallah › Device Explorer › Orthopaedic implants › Elbow ulna prosthesis trial
Device Explorer · FDA GUDID · GMDN 58751

Elbow ulna prosthesis trial

A copy of a final ulna prosthesis designed to be used for trial reductions during elbow arthroplasty to judge the correct sizing, length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes and is typic

US‑registered devices116in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Tornier, Inc.4539%
Biomet Orthopedics, Llc3530%
Zimmer, Inc.2522%
Limacorporate Spa119%

Top labelers

CompanyDevicesShare
Tornier, Inc.4539%
Biomet Orthopedics, Llc3530%
Zimmer, Inc.2522%
Limacorporate Spa119%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ulna Provisional BearingNANexel®DISCOVERY ELBOWDISCOVERY ELBOW CONDYLE PROVISIONALDISCOVERY ELBOW RIGHT HUMERAL TRIALTornier LatitudeTEMA Elbow

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

FDA product codes

CodeNameDevices
HWTTEMPLATE47
LXHOrthopedic manual surgical instrument45
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED12
JDBProsthesis, Elbow, Semi-Constrained, Cemented9
JDCProsthesis, Elbow, Constrained, Cemented9
LXHOrthopedic Manual Surgical Instrument2

GMDN & GCC registration

  • GMDN code 58751 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 100% · 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

Length (Millimeter) · 36Length (Inch) · 12

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

How many elbow ulna prosthesis trial products are registered in the US?

116 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Elbow ulna prosthesis trial", from 4 companies. The largest labeler is Tornier, Inc. with 39% of records.

Which FDA product codes apply?

HWT (TEMPLATE), LXH (Orthopedic manual surgical instrument), JDC (PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED), JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)

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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