Perfix™ Spinal System

79 catalogue numbers from SN0007F, listed by CG MedTech Co., Ltd., South Korea, under Screwdriver. 18 manufacturers in China are registered for this product code.

Registry build 21.09.26
18manufacturers in China registered for this device type
79catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Shanghai (3), Guangdong (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HXX
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
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
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Autocam Medical Devices (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Changzhou Wastonortho Medical Appliance Co., Ltd. Changzhou Jiangsu Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82

Showing 12 of 18. All 18 manufacturers in China registered for Screwdriver

Record

Regulatory record for Perfix™ Spinal System
Listed by CG MedTech Co., Ltd., South Korea
FDA product code HXX
Device type Screwdriver
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-10-27
Record revised 2025-01-06 (version 7)

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 Perfix™ Spinal System
Catalogue number Size Status
SN0007F In distribution
SN0008 In distribution
SN0043 In distribution
SN0056 In distribution
SNS0032 In distribution
SI0190 In distribution
SN1090C In distribution
SN0054 In distribution
SN0055 In distribution
SN0012 In distribution
SN0054 In distribution
SN0014 In distribution
SN0014 In distribution
SN0053 In distribution
SN0055 In distribution
SNS0020 In distribution
SN0051 In distribution
SNS0019 In distribution
SN0055 In distribution
SN0043 In distribution
SN0056 In distribution
SN0055 In distribution
SNS0016 In distribution
SN0052 In distribution
SN0054 In distribution
SNS0020 In distribution
SNS0014 In distribution
SNS0019 In distribution
SNS0001 In distribution
SN0052 In distribution
SN0026 In distribution
SN0056 In distribution
SN0051 In distribution
SN0041 In distribution
SN0026 In distribution
SE0040 In distribution
SN0053 In distribution
SNS0030 In distribution
SN0054 In distribution
SN1090C In distribution
SN0041 In distribution
SN0056 In distribution
ST9019R In distribution
SNS0017 In distribution
SN0008 In distribution
SN0045 In distribution
SN0046 In distribution
SNS0019 In distribution
SN0048 In distribution
SN0047 In distribution
SN0007F In distribution
SN0055 In distribution
SNS0020 In distribution
SNS0017 In distribution
SN0007 In distribution
SNS0018 In distribution
SN0013 In distribution
SN0013 In distribution
SN0054 In distribution
ST9018R In distribution
SN0044 In distribution
SN0045 In distribution
SNS0018 In distribution
SNS0015 In distribution
SNS0015 In distribution
SN0007 In distribution
SN1090C In distribution
SNS0016 In distribution
SN0012 In distribution
SN0007 In distribution
SNS0017 In distribution
SN0024 In distribution
SN0043 In distribution
SN0055 In distribution
SN0047 In distribution
SNS1001 In distribution
SN0012 In distribution
SN0013 In distribution
SNS0018 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tecomet Tecomet, Inc. 939
Screwdriver Synthes Gmbh 485
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 371
Screwdriver Medtronic Sofamor Danek, Inc. 197
Level ONE KLS-Martin L.P. 153
Surgical Instrument Jeil Medical Corporation 116
Invictus Alphatec Spine, Inc. 115
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 110
Bradshaw Medical Inc. Bradshaw Medical Inc. 109
Screwdriver Depuy Spine, Inc. 99
Generic Surgical Instruments CTL Medical Corporation 93
Surgical Direct Surgical Direct, Inc. 85

Showing 12 of 1,263. All products under Screwdriver

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