Perfix™ Spinal System

1,476 catalogue numbers from SNM7565, listed by CG MedTech Co., Ltd., South Korea, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.

Registry build 21.09.26
13manufacturers in China registered for this device type
1,476catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MNH
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
APS Materials Suzhou Suzhou Jiangsu Contract manufacturer 18
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Changzhou Yonghua Medical Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 8
Jiangsu Ideal Medical Science & Technology Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7

Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation

Record

Regulatory record for Perfix™ Spinal System
Listed by CG MedTech Co., Ltd., South Korea
FDA product code MNH
Device type Orthosis, Spondylolisthesis Spinal Fixation
Device class Class 2
Regulation 21 CFR 888.3070
Establishment Complaint-file establishment, Manufacturer
510(k) K091725
Record published 2023-02-25
Record revised 2025-07-14 (version 8)

Specifications

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

Catalogue Numbers

Catalogue numbers for Perfix™ Spinal System
Catalogue number Size Status
SNM7565 In distribution
SNM7680 In distribution
SNM6670 In distribution
SNA5565 In distribution
SNM9635 In distribution
SNM6645 In distribution
SNA8060C In distribution
SR6040TC In distribution
SNM8150 In distribution
SNM8675 In distribution
SNA9565 In distribution
SNM8640 In distribution
SNM8040 In distribution
SNA8630C In distribution
SNA6535C In distribution
SNA8145C In distribution
SNA5040 In distribution
SNA7650C In distribution
SNA8145C In distribution
SNM8140 In distribution
SNM6050 In distribution
SNA5630C In distribution
SNM6635 In distribution
SR6050TCL In distribution
SNM6650 In distribution
SNM9095 In distribution
SNA8630C In distribution
SNM8590 In distribution
SNA7165 In distribution
SNA5145 In distribution
SR6035CCL In distribution
SNA8055 In distribution
SNA7650 In distribution
SR6110CCL In distribution
SNA5535C In distribution
SNA7040C In distribution
SNA5060 In distribution
SNA7540C In distribution
SNA9130 In distribution
SNM5535 In distribution
SNM7035 In distribution
SNM8035 In distribution
SR6130TC In distribution
SNA6130 In distribution
SR6170TS In distribution
SNA7150 In distribution
SR6260TS In distribution
SNM9155 In distribution
SNA7660 In distribution
SNA8545 In distribution
SNM8085 In distribution
SR6110CS In distribution
SR6350TSL In distribution
SNM5540 In distribution
SNM8565 In distribution
SNA8695C In distribution
SNA6635 In distribution
SNA5180 In distribution
SR6150TC In distribution
SR6200TS In distribution
SNA7540 In distribution
SNA5675 In distribution
SNA8045C In distribution
SNM5160 In distribution
SR6110TC In distribution
SR6120TC In distribution
SNA9570 In distribution
SNM6040 In distribution
SNM6655 In distribution
SNM9065 In distribution
SNA7535 In distribution
SNM5065 In distribution
SNM8655 In distribution
SNM7035 In distribution
SNM9550 In distribution
SNA8530C In distribution
SNM7040 In distribution
SNM9180 In distribution
SNM7630 In distribution
SNM6660 In distribution
SNM9085 In distribution
SR6070CSL In distribution
SNM9590 In distribution
SNM7060 In distribution
SNA7535C In distribution
SNA9590 In distribution
SNM8145 In distribution
SNM7135 In distribution
SNA8685C In distribution
SNM5670 In distribution
SNA4550 In distribution
SR6080CC In distribution
SNA8590 In distribution
SNM7660 In distribution
SNM4635 In distribution
SNA7050 In distribution
SNA8065C In distribution
SN3020 In distribution
SNM7055 In distribution
SNA6530C In distribution
SNA6640 In distribution
SR6200CSL In distribution
SR6060TCL In distribution
SNA8595 In distribution
SNM5660 In distribution
SNA6030C In distribution
SNA8695 In distribution
SNM5150 In distribution
SNA6075 In distribution
SNA7170 In distribution
SNA7550C In distribution
SNM8170 In distribution
SNM9575 In distribution
SNA4640 In distribution
SNA8685 In distribution
SNA8660C In distribution
SNM4680 In distribution
SNM8670 In distribution
SNM8035 In distribution
SNA5575 In distribution
SNA7055C In distribution
SNM5570 In distribution
SNA6660C In distribution
SNM8145 In distribution
SG1611CS In distribution
SNA8030C In distribution
SNA8050C In distribution
SNA8650 In distribution
SNM8635 In distribution
SNM8610 In distribution
SR6070CS In distribution
SR6190TSL In distribution
SNA4570 In distribution
SNA6045 In distribution
SNA8090C In distribution
SNA8590C In distribution
SNA9680 In distribution
SNA5175 In distribution
SR6150TS In distribution
SNA6065 In distribution
SNA6055 In distribution
SNA8575 In distribution
SNA4680 In distribution
SNM8165 In distribution
SNM9660 In distribution
SNA9550 In distribution
SG1909CC In distribution
SNM5530 In distribution
SR6070CC In distribution
SR6190CSL In distribution
SNA4670 In distribution
SNA8650 In distribution
SNA8095 In distribution
SNA8140C In distribution
SNM8510 In distribution
SNA9650 In distribution
SNM9580 In distribution
SNA8045 In distribution
SNM5155 In distribution
SNM8690 In distribution
SNM9530 In distribution
SNM9650 In distribution
SNA5640C In distribution
SNA6050 In distribution
SNA7055 In distribution
SNA8070C In distribution
SNM9030 In distribution
SNA7595 In distribution
SNM7660 In distribution
SNA4635 In distribution
SNA6055 In distribution
SNM7670 In distribution
SNA8035C In distribution
SNA6175 In distribution
SNA7535C In distribution
SNA8545C In distribution
SR6070CCL In distribution
SNA4635 In distribution
SNM8065 In distribution
SNA5540C In distribution
SNA7590 In distribution
SNA8545C In distribution
SNA4660 In distribution
SNA6175 In distribution
SNA9075 In distribution
SNA8055C In distribution
SR6130CSL In distribution
SR6045CC In distribution
SR6140TCL In distribution
SNA8135C In distribution
SNM9040 In distribution
SNA6575 In distribution
SNA7640 In distribution
SNM6630 In distribution
SR6060CCL In distribution
SNA7640C In distribution
SNA7565 In distribution
SNM8635 In distribution
SR6035TC In distribution
SNA8055 In distribution
SNM8045 In distribution
SNA8650C In distribution
SR6135CSL In distribution
SNM4565 In distribution
SNA5660C In distribution
SNM5670 In distribution
SNM5560 In distribution
SNA8085 In distribution
SNM8575 In distribution
SNM4560 In distribution
SNM8540 In distribution
SNA8110 In distribution
SNM9665 In distribution
SNM6030 In distribution
SNA7660C In distribution
SNM7645 In distribution
SNA9010 In distribution
SR6090TCL In distribution
SNA8010C In distribution
SNA8610 In distribution
SNM8560 In distribution
SNA6565 In distribution
SNA5630 In distribution
SNA7145 In distribution
SNM5680 In distribution
SNA8155 In distribution
SNA5550C In distribution
SNM5165 In distribution
SNA5130 In distribution
SNA8690 In distribution
SNA7675 In distribution
SNA7575 In distribution
SNM9175 In distribution
SNA8155C In distribution
SNM9055 In distribution
SR6170CSL In distribution
SNA7040 In distribution
SNA4675 In distribution
SNA8555 In distribution
SNM5575 In distribution
SNA8510C In distribution
SNM9055 In distribution
SN3030 In distribution
SNA8045C In distribution
SNA4655 In distribution
SNA6140 In distribution
SE1614 In distribution
SR6120CS In distribution
SNA7175 In distribution
SR6280CS In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 3,144
Anax™ 5.5 Spinal System CG MedTech Co., Ltd. 2,177
ReLine Nuvasive, Inc. 2,010
Creo Globus Medical, Inc. 1,619
Apex Spine System Spinecraft LLC 1,193
Olympic Astura Medical 1,173
Arsenal Alphatec Spine, Inc. 1,001
Revere Globus Medical, Inc. 997
Astra Spine System Spinecraft LLC 798
Apex-DL Spine System Spinecraft LLC 735
Zenius Spinal System Medyssey Co., Ltd. 712
Polaris 5.5 Spinal System Biomet Spine 707

Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation

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