Consulting Wallah › Device Explorer › Syringes, needles & infusion › Vertebral body cement cannula
Device Explorer · FDA GUDID · GMDN 58032

Vertebral body cement cannula

A sterile, manual, tubular device designed to create a percutaneous access channel into a vertebral body prior to and during injection of orthopaedic cement into the vertebral body during kyphoplasty. It is typically inserted under fluoroscopic guidance to tre

US‑registered devices81in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription41%Rx‑only share
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Share of device records

Merit Medical Systems, Inc.4960%
G21 Srl1519%
Stryker Corporation79%
Biopsybell Srl67%
Teknimed45%

Top labelers

CompanyDevicesShare
Merit Medical Systems, Inc.4960%
G21 Srl1519%
Stryker Corporation79%
Biopsybell Srl67%
Teknimed45%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VertePortNAVertebroplasty needlesKyphoFlex™StabiliT®VertecoR®Merit Medical®Osseoflex®DFINE®PowerCURVE®KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16KeyFix Direct Access Needle Trocar and bevel tipKeyfix Bone Cement Filler Cannula 9GKeyfix direct access needle 8GFlex FillerV-Access

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

FDA product codes

CodeNameDevices
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE29
OCJSpinal Channeling Instrument, Vertebroplasty15
OARInjector, Vertebroplasty (Does Not Contain Cement)7
OARInjector, vertebroplasty (does not contain cement)6
LXHOrthopedic manual surgical instrument5
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT5

GMDN & GCC registration

  • GMDN code 58032 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 41% · 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) · 13Length (Millimeter) · 4Length (Centimeter) · 3Outer Diameter (Millimeter) · 1

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

No closely related category with 50+ devices.

How many vertebral body cement cannula products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vertebral body cement cannula", from 5 companies. The largest labeler is Merit Medical Systems, Inc. with 60% of records.

Which FDA product codes apply?

MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), OCJ (Spinal Channeling Instrument, Vertebroplasty), OAR (Injector, Vertebroplasty (Does Not Contain Cement)), 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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