Balloon Inflator

20 mL capacity, A type, with 10 mL syringe

Registry build 21.09.26
7manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HXG
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Shanghai Lange Medtech Co., Ltd. Shanghai Shanghai Manufacturer 16
Jiangsu Changmei Medtech Co., Ltd. Changzhou Jiangsu Contract manufacturer 8

Record

Regulatory record for Balloon Inflator
Listed by Jiangsu Changmei Medtech Co., Ltd., China
FDA product code HXG
Device type Tamp
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2025-10-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature up to 80 % RH

Catalogue Numbers

Catalogue numbers for Balloon Inflator
Catalogue number Size Status
BI-20A-10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 78
Life Instruments Life Instrument Corp. 56
4WEB Medical 4WEB Inc. 35
General Instruments Alphatec Spine, Inc. 31
CPT® Zimmer, Inc. 30
Novel Alphatec Spine, Inc. 29
IdentiTi Alphatec Spine, Inc. 29
Tamp Depuy Spine, Inc. 27
Tamp Synthes Gmbh 21
Boss Instruments Boss Instruments, Ltd. 19
Millennium Avalign Technologies, Inc. 18
Aesculap Aesculap AG 17

Showing 12 of 267. All products under Tamp

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer