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Device Explorer · FDA GUDID · GMDN 37065

Ultrasonic orthopaedic cement extractor

A hand-operated, electrically-powered surgical instrument that uses ultrasonic energy for the extraction of orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN cod

US‑registered devices64in commercial distribution
Companies2labelers on GUDID
Single‑use70%of device records
Sterile70%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Orthosonics Limited3656%
Henry Schein, Inc.2844%

Top labelers

CompanyDevicesShare
Orthosonics Limited3656%
Henry Schein, Inc.2844%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OSCARHenry Schein

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

FDA product codes

CodeNameDevices
JDXInstrument, Surgical, Sonic And Accessory/Attachment36
LZVSystem, Cement Removal Extraction35
GESBLADE, SCALPEL21
GDXSCALPEL, ONE-PIECE7

GMDN & GCC registration

  • GMDN code 37065 · non‑implantable
  • Single‑use 70% · sterile 70% · Rx‑only 56% · OTC 44%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 14Outer Diameter (Millimeter) · 8Length (Millimeter) · 4

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

How many ultrasonic orthopaedic cement extractor products are registered in the US?

64 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultrasonic orthopaedic cement extractor", from 2 companies. The largest labeler is Orthosonics Limited with 56% of records.

Which FDA product codes apply?

JDX (Instrument, Surgical, Sonic And Accessory/Attachment), LZV (System, Cement Removal Extraction), GES (BLADE, SCALPEL), GDX (SCALPEL, ONE-PIECE)

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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