Consulting Wallah › Device Explorer › Procedure kits & trays › Orthopaedic cement preparation/delivery kit
Device Explorer · FDA GUDID · GMDN 45253

Orthopaedic cement preparation/delivery kit

A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a malle

US‑registered devices366in commercial distribution
Companies22labelers on GUDID
Single‑use97%of device records
Sterile90%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Imedicom Co., Ltd.8623%
Merit Medical Systems, Inc.5615%
Summit Medical Limited308%
Stryker Corporation288%
Tecres Spa288%
Teknimed247%
Smith & Nephew, Inc.236%
Biopsybell Srl185%

Top labelers

CompanyDevicesShare
Imedicom Co., Ltd.8623%
Merit Medical Systems, Inc.5615%
Summit Medical Limited308%
Stryker Corporation288%
Tecres Spa288%
Teknimed247%
Smith & Nephew, Inc.236%
Biopsybell Srl185%
Synthes Gmbh164%
G21 Srl164%
Shanghai Kinetic Medical Co., Ltd.123%
Möller Medical Gmbh72%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AutoPlex M4AutoPlex VertaPlexAutoPlexLITe BioPCD, VertaPlexRELIANCE LITeLITe BIO Delivery SystemVertaPlexHowmedicaNAACMKMC Bone Cement Delivery SystemBone Cement Injection GunBone Cement Filler DevicesRevolutionACM BioPrep

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

FDA product codes

CodeNameDevices
OARInjector, Vertebroplasty (Does Not Contain Cement)70
NDNCement, Bone, Vertebroplasty63
JDZMixer, Cement, For Clinical Use57
LXHOrthopedic Manual Surgical Instrument46
KIHDispenser, Cement44
NDNCEMENT, BONE, VERTEBROPLASTY41

GMDN & GCC registration

  • GMDN code 45253 · non‑implantable
  • Single‑use 97% · sterile 90% · Rx‑only 71% · 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

Needle Gauge (Gauge) · 20Length (Centimeter) · 15Pressure (Pound per Square Inch) · 11Outer Diameter (Millimeter) · 8Length (Millimeter) · 8Weight (Gram) · 5

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

How many orthopaedic cement preparation/delivery kit products are registered in the US?

366 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic cement preparation/delivery kit", from 22 companies. The largest labeler is Imedicom Co., Ltd. with 23% of records.

Which FDA product codes apply?

OAR (Injector, Vertebroplasty (Does Not Contain Cement)), NDN (Cement, Bone, Vertebroplasty), JDZ (Mixer, Cement, For Clinical Use), 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.

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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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