Intervertebral Body Fusion Device

Curette Teardrop Right angle 8mm

Registry build 21.09.26
11manufacturers in China registered for this device type
20catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (4), Jiangsu (3), Shandong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTF
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Huaian Wolfram Surgical Instruments Huaian Jiangsu Manufacturer 14

Record

Regulatory record for Intervertebral Body Fusion Device
Listed by Precision Spine, Inc., United States
FDA product code HTF
Device type Curette
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Manufacturer
Premarket notification Exempt
Record published 2019-03-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Intervertebral Body Fusion Device
Catalogue number Size Status
ALN013 In distribution
12-9018 In distribution
ALN014 In distribution
ALN010 In distribution
ALN009 In distribution
ALN005 In distribution
ALN011 In distribution
ALN016 In distribution
12-9015 In distribution
ALN008 In distribution
12-9011 In distribution
ALN015 In distribution
12-9019 In distribution
ALN012 In distribution
12-9009 In distribution
ALN006 In distribution
12-9017 In distribution
12-9016 In distribution
12-9010 In distribution
ALN007 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Orthomed Ortho-MED, Inc. 341
Intervertebral Disc Preparation Instruments Alphatec Spine, Inc. 276
General Instruments Alphatec Spine, Inc. 252
MSI Precision Specialty Instruments MED Saver, Inc. 242
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 240
Millennium Avalign Technologies, Inc. 233
Curette Depuy Spine, Inc. 203
Curette George Tiemann & Co. 179
Timberline Lateral Fusion System Highridge Medical, LLC 135
Battalion Alphatec Spine, Inc. 131
Ambler Surgical Ambler Surgical, LLC 129
Curette Synthes Gmbh 127

Showing 12 of 258. All products under Curette

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