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Device Explorer · FDA GUDID · GMDN 35809

Orthopaedic cement dispenser

A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

US‑registered devices130in commercial distribution
Companies24labelers on GUDID
Single‑use82%of device records
Sterile68%labelled sterile
Prescription58%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.3628%
Surgentec, Llc1814%
Young Innovations, Inc.1612%
Stryker Corporation108%
Izi Medical Products, Llc86%
Biomet75%
Abyrx, Inc.43%
Degen Medical, Inc.43%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.3628%
Surgentec, Llc1814%
Young Innovations, Inc.1612%
Stryker Corporation108%
Izi Medical Products, Llc86%
Biomet75%
Abyrx, Inc.43%
Degen Medical, Inc.43%
Carbofix Orthopedics Ltd32%
Joline Gmbh & Co. Kg32%
Merit Medical Systems, Inc.32%
Biomet Orthopedics, Llc32%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTVertePort X4 ManifoldCement Delivery SystemAngled NozzleKnee Cementation NozzleOptivac Nozzle RevisionOptivac Nozzle SlimCarboClear Hybrid Pedicle Screw SystemCarboClear Pedicle Screw SystemGun-shaped Bone Cement Filler DevicesPALAMIX®Vertebra Filler Device Flex Plunger (Frontal OpeVertebra Filler Device (Side Opening)Vertebra Filler Device (Frontal Opening)SpineJackGRAFTYS® DELIVERING GUN

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

FDA product codes

CodeNameDevices
KIHDISPENSER, CEMENT50
FMFSyringe, Piston21
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL16
OARInjector, vertebroplasty (does not contain cement)8
OARInjector, Vertebroplasty (Does Not Contain Cement)7
KIHDispenser, Cement7

GMDN & GCC registration

  • GMDN code 35809 · non‑implantable
  • Single‑use 82% · sterile 68% · Rx‑only 58% · 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) · 6Total Volume (Milliliter) · 2

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

How many orthopaedic cement dispenser products are registered in the US?

130 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic cement dispenser", from 24 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 28% of records.

Which FDA product codes apply?

KIH (DISPENSER, CEMENT), FMF (Syringe, Piston), EID (SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL), OAR (Injector, vertebroplasty (does not contain cement))

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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