Consulting Wallah › Device Explorer › Procedure kits & trays › Balloon kyphoplasty kit
Device Explorer · FDA GUDID · GMDN 47129

Balloon kyphoplasty kit

A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically cons

US‑registered devices900in commercial distribution
Companies14labelers on GUDID
Single‑use99%of device records
Sterile95%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Zavation Llc41046%
Imedicom Co., Ltd.23326%
Medtronic Sofamor Danek, Inc.10111%
Gs Medical Co., Ltd.404%
Stryker Corporation364%
Shanghai Kinetic Medical Co., Ltd.324%
Joline Gmbh & Co. Kg142%
Izi Medical Products, Llc121%

Top labelers

CompanyDevicesShare
Zavation Llc41046%
Imedicom Co., Ltd.23326%
Medtronic Sofamor Danek, Inc.10111%
Gs Medical Co., Ltd.404%
Stryker Corporation364%
Shanghai Kinetic Medical Co., Ltd.324%
Joline Gmbh & Co. Kg142%
Izi Medical Products, Llc121%
G21 Srl121%
Nerveaction Solutions Inc.40%
Globus Medical, Inc.30%
Mediox Medical Service Ltd10%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OmnicurveAVAflexIVASiVASKMC OneShot Single Balloon Assembly, 10 Gauge, 2KMC OneShot Single Balloon Assembly, 10 Gauge, 1KMC OneShot Single Balloon Assembly, 10 Gauge, 1KMC OneShot Double Balloon Assembly, 10 Gauge, 2KMC OneShot Double Balloon Assembly, 10 Gauge, 1KMC OneShot Double Balloon Assembly, 10 Gauge, 1KMC OneShot Single Balloon Assembly, 8 Gauge, 20KMC OneShot Single Balloon Assembly, 8 Gauge, 15KMC OneShot Single Balloon Assembly, 8 Gauge, 10KMC OneShot Double Balloon Assembly, 8 Gauge, 20KMC OneShot Double Balloon Assembly, 8 Gauge, 15KMC OneShot Double Balloon Assembly, 8 Gauge, 10

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

FDA product codes

CodeNameDevices
HRXArthroscope836
NDNCement, Bone, Vertebroplasty761
GAANeedle, Aspiration And Injection, Disposable417
HXGTamp199
HRXARTHROSCOPE73
NDNCEMENT, BONE, VERTEBROPLASTY46

GMDN & GCC registration

  • GMDN code 47129 · non‑implantable
  • Single‑use 99% · sterile 95% · Rx‑only 92% · 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) · 84Length (Millimeter) · 29Balloon Length (Millimeter) · 25

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

No closely related category with 50+ devices.

How many balloon kyphoplasty kit products are registered in the US?

900 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Balloon kyphoplasty kit", from 14 companies. The largest labeler is Zavation Llc with 46% of records.

Which FDA product codes apply?

HRX (Arthroscope), NDN (Cement, Bone, Vertebroplasty), GAA (Needle, Aspiration And Injection, Disposable), HXG (Tamp)

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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