Anax 5.5 Spinal System

36 catalogue numbers from SFDS1003, listed by CG MedTech Co., Ltd., South Korea, under Probe. 12 manufacturers in China are registered for this product code.

Registry build 21.09.26
12manufacturers in China registered for this device type
36catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (4), Jiangsu (4), 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 HXB
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Hangzhou Haizhu MIM Products Co., Ltd. Hangzhou Zhejiang Exporter 28
Suzhou Endophix Co., Ltd. Suzhou Jiangsu Manufacturer 17
Hangzhou Ruihao Medical Technology Ltd Hangzhou Zhejiang Contract manufacturer 12
Changzhou Xietong Industries Co., Ltd. Changzhou Jiangsu Exporter 11

Record

Regulatory record for Anax 5.5 Spinal System
Listed by CG MedTech Co., Ltd., South Korea
FDA product code HXB
Device type Probe
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-08-13
Record revised 2025-01-06 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
Storage Special storage condition: Store in a cool dry place.

Catalogue Numbers

Catalogue numbers for Anax 5.5 Spinal System
Catalogue number Size Status
SFDS1003 In distribution
SFS1058 In distribution
SF0280 In distribution
SFMS0380 In distribution
SFD0090 In distribution
SFD0080 In distribution
SFD0070 In distribution
SF0450 In distribution
SFS1057 In distribution
SFD0080 In distribution
SFD0080 In distribution
SFD0070 In distribution
SFD0080 In distribution
SF0350 In distribution
SF0290 In distribution
SFD0090 In distribution
SFD0100 In distribution
SFS1052 In distribution
SFD0100 In distribution
SFD0090 In distribution
SF0350 In distribution
SFS1051 In distribution
SFMS0130 In distribution
SF0360 In distribution
SFD0090 In distribution
SFDS1003 In distribution
SFD0100 In distribution
SF0460 In distribution
SFD0070 In distribution
SFD0100 In distribution
SFD0070 In distribution
SFS1054 In distribution
SF0460 In distribution
SF0450 In distribution
SFS1055 In distribution
SF0360 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. 219
Probe Depuy Spine, Inc. 190
Probe Zimmer Trabecular Metal Technology, Inc. 154
Sklar® Sklar Corporation 136
General Instruments Alphatec Spine, Inc. 112
Life Instruments Life Instrument Corp. 107
Tecomet Tecomet, Inc. 97
Tetris ST Signus Medizintechnik Gmbh 65
Invictus Alphatec Spine, Inc. 64
Medtronic Resuable Instruments Medtronic Sofamor Danek, Inc. 56
Probe Synthes Gmbh 47
Tasmin R Signus Medizintechnik Gmbh 47

Showing 12 of 330. All products under Probe

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