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Device Explorer · FDA GUDID · GMDN 47021

Inflatable bone tamp

A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is comm

US‑registered devices196in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile84%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Merit Medical Systems, Inc.9146%
Medtronic Sofamor Danek, Inc.4523%
Shanghai Kinetic Medical Co., Ltd.158%
Imedicom Co., Ltd.126%
Osseon Llc63%
Synthes Gmbh63%
Stryker Corporation53%
G21 Srl42%

Top labelers

CompanyDevicesShare
Merit Medical Systems, Inc.9146%
Medtronic Sofamor Danek, Inc.4523%
Shanghai Kinetic Medical Co., Ltd.158%
Imedicom Co., Ltd.126%
Osseon Llc63%
Synthes Gmbh63%
Stryker Corporation53%
G21 Srl42%
Biopsybell Srl42%
Shanghai Lange Medtech Co., Ltd.32%
Han Chang Co., Ltd32%
Globus Medical, Inc.21%

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

Brand names on the register (sample)

iVASKMC Balloon Catheter Curved, 10 Gauge, 45°, 25mmKMC Balloon Catheter Curved, 10 Gauge, 45°, 20mmKMC Balloon Catheter Curved, 10 Gauge, 45°, 15mmKMC Balloon Catheter, 10 Gauge, 20mmKMC Balloon Catheter, 10 Gauge, 15mmKMC Balloon Catheter, 10 Gauge, 10mmKMC Balloon Catheter, 8 Gauge, 20mmKMC Balloon Catheter, 8 Gauge, 15mmKMC Balloon Catheter, 8 Gauge, 10mmBalloon CatheterKyphoplasty Balloon Dilatation CathetersALVUEKyphoFlex™Arcadia™Osseoflex®

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

FDA product codes

CodeNameDevices
HRXArthroscope144
NDNCement, Bone, Vertebroplasty73
HXGTamp33
HRXARTHROSCOPE30
NDNCEMENT, BONE, VERTEBROPLASTY24
HXGTAMP21

GMDN & GCC registration

  • GMDN code 47021 · non‑implantable
  • Single‑use 100% · sterile 84% · Rx‑only 49% · 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) · 30Balloon Length (Millimeter) · 20Length (Millimeter) · 12Total Volume (Milliliter) · 6Angle (degree) · 3Outer Diameter (Millimeter) · 3

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

How many inflatable bone tamp products are registered in the US?

196 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inflatable bone tamp", from 12 companies. The largest labeler is Merit Medical Systems, Inc. with 46% of records.

Which FDA product codes apply?

HRX (Arthroscope), NDN (Cement, Bone, Vertebroplasty), HXG (Tamp), HRX (ARTHROSCOPE)

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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