Niagara® Lateral Access System

Guidewire Pack, Size Ø1.7mm SS (Qty 1)

Registry build 21.09.26
53manufacturers in China registered for this device type
342catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LXH
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
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
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17

Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument

Record

Regulatory record for Niagara® Lateral Access System
Listed by VB Spine LLC
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2021-03-11
Record revised 2026-04-20 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Sizes Length 20 to 290 mm; width 8 to 30 mm; outer diameter 6 to 22 mm

Catalogue Numbers

Catalogue numbers for Niagara® Lateral Access System
Catalogue number Size Status
PRO-1021-17 Length 100 mm In distribution
SP-4204-25 Length 170 mm In distribution
AC01-90069 Length 110 mm In distribution
AC01-90095 Length 220 mm In distribution
PRO-1265-06 Width 19 mm In distribution
PRO-1099-02 Length 90 mm In distribution
AC01-90012 Length 90 mm In distribution
AC01-90023 Length 200 mm In distribution
AC01-90093 Length 200 mm In distribution
SP-4204-07 Length 140 mm In distribution
PRO-1021-04 Width 20 mm In distribution
AC01-90110 In distribution
SP-4204-26 Length 180 mm In distribution
SP-4204-11 Length 180 mm In distribution
AC01-90063 In distribution
PRO-1252-02 Length 250 mm In distribution
PRO-1265-16 Width 19 mm In distribution
PRO-1265-26 Width 24 mm In distribution
PRO-1099-04 Length 110 mm In distribution
PRO-1025-06 In distribution
SP-4124-01 Outer Diameter 8 mm In distribution
PRO-1005 Outer Diameter 6 mm In distribution
PRO-1099-15 Length 220 mm In distribution
PRO-1265-24 Length 140 mm In distribution
AC01-90005 In distribution
PRO-1074-17 Length 90 mm In distribution
PRO-1099-10 Length 170 mm In distribution
PRO-1023-08 Length 150 mm In distribution
PRO-1034-01 Length 60 mm In distribution
PRO-1074-04 Length 110 mm In distribution
PRO-1265-42 Length 150 mm In distribution
PRO-1265-31 Width 24 mm In distribution
SP-4124-02 Outer Diameter 12 mm In distribution
SP-4122-06 Length 290 mm In distribution
AC01-90081 Length 80 mm In distribution
PRO-1265-41 Width 24 mm In distribution
AC01-90050 In distribution
AC01-90107 In distribution
AC01-90009 In distribution
PRO-1024-11 Length 180 mm In distribution
SP-4204-23 Length 150 mm In distribution
PRO-1080-08 Length 150 mm In distribution
AC01-90111 In distribution
AC01-90043 In distribution
SP-4122-04 Width 13 mm In distribution
PRO-1265-32 Length 220 mm In distribution
AC01-90080 Length 220 mm In distribution
AC01-90013 Length 100 mm In distribution
PRO-1265-19 Width 24 mm In distribution
SP-4204-18 Length 100 mm In distribution
SP-4124-03 Outer Diameter 18 mm In distribution
AC01-90079 Length 210 mm In distribution
SP-4204-13 Length 200 mm In distribution
PRO-1099-13 Length 200 mm In distribution
SP-4204-27 Length 190 mm In distribution
SP-4245-02 In distribution
PRO-1074-29 Length 210 mm In distribution
AC01-90073 Length 150 mm In distribution
PRO-1265-23 Length 130 mm In distribution
PRO-1034-04 Length 40 mm In distribution
PRO-1265-36 Length 90 mm In distribution
PRO-1024-10 Length 170 mm In distribution
PRO-1030-01 In distribution
PRO-1021-12 Length 160 mm In distribution
PRO-1265-43 Width 24 mm In distribution
PRO-1265-20 Length 100 mm In distribution
PRO-1074-02 Length 90 mm In distribution
SP-4221-12 Length 190 mm In distribution
PRO-1074-21 Length 130 mm In distribution
PRO-1265-48 Width 24 mm In distribution
SP-4221-15 Length 220 mm In distribution
PRO-1074-27 Length 190 mm In distribution
PRO-1024-09 Length 160 mm In distribution
AC01-90085 Length 120 mm In distribution
PRO-1265-12 Width 19 mm In distribution
PRO-1080-04 Length 110 mm In distribution
PRO-1023-13 Length 200 mm In distribution
PRO-1074-22 Length 140 mm In distribution
PRO-1074-25 Length 170 mm In distribution
PRO-1033-01 Length 60 mm In distribution
PRO-1034-05 Length 50 mm In distribution
AC01-90113 In distribution
PRO-1146-02 In distribution
PRO-1021-01 In distribution
SP-4204-29 Length 210 mm In distribution
AC01-90020 Length 170 mm In distribution
SP-4122-02 Width 8 mm In distribution
PRO-1074-11 Length 180 mm In distribution
AC01-90025 Length 220 mm In distribution
PRO-1074-08 Length 150 mm In distribution
SP-4204-16 Length 80 mm In distribution
SP-4204-14 Length 210 mm In distribution
SP-4221-03 Length 100 mm In distribution
SP-4221-11 Length 180 mm In distribution
SP-4122-01 Width 8 mm In distribution
PRO-1024-06 Length 130 mm In distribution
PRO-1080-02 Length 90 mm In distribution
PRO-1265-29 Width 24 mm In distribution
PRO-1033-03 Length 30 mm In distribution
AC01-90041 In distribution
AC01-90099 In distribution
PRO-1265-33 Width 24 mm In distribution
AC01-90058 In distribution
PRO-1023-10 Length 170 mm In distribution
PRO-1386 In distribution
AC01-90087 Length 140 mm In distribution
PRO-1099-05 Length 120 mm In distribution
PRO-1265-15 Width 19 mm In distribution
PRO-1021-05 Width 20 mm In distribution
AC01-90018 Length 150 mm In distribution
PRO-1099-03 Length 100 mm In distribution
PRO-1265-05 Length 120 mm In distribution
SP-4221-14 Length 210 mm In distribution
PRO-1074-07 Length 140 mm In distribution
PRO-1074-28 Length 200 mm In distribution
AC01-90019 Length 160 mm In distribution
SP-4219 Length 30 mm In distribution
PRO-1099-01 Length 80 mm In distribution
PRO-1021-03 Length 70 mm In distribution
PRO-1080-10 Length 170 mm In distribution
PRO-1023-09 Length 160 mm In distribution
PRO-1265-25 Width 24 mm In distribution
AC01-90092 Length 190 mm In distribution
PRO-1025-05 In distribution
PRO-1265-28 Width 24 mm In distribution
SP-4221-07 Length 140 mm In distribution
SP-4204-09 Length 160 mm In distribution
PRO-1024-02 Length 90 mm In distribution
PRO-1074-23 Length 150 mm In distribution
PRO-1265-04 Length 110 mm In distribution
PRO-1074-26 Length 180 mm In distribution
PRO-1265-22 Length 120 mm In distribution
PRO-1265-46 Length 190 mm In distribution
PRO-1265-21 Width 24 mm In distribution
PRO-1033-05 Length 50 mm In distribution
PRO-1021-22 Width 30 mm In distribution
PRO-1080-06 Length 130 mm In distribution
PRO-1024-14 Length 210 mm In distribution
AC01-90075 Length 170 mm In distribution
PRO-1074-14 Length 210 mm In distribution
AC01-90076 Length 180 mm In distribution
PRO-1034-02 Length 70 mm In distribution
PRO-1099-12 Length 190 mm In distribution
SP-4204-30 Length 220 mm In distribution
PRO-1265-01 Length 80 mm In distribution
AC01-90064-G4 In distribution
PRO-1023-14 Length 210 mm In distribution
SP-4122-03 Length 240 mm In distribution
SP-4221-01 Length 80 mm In distribution
AC01-90059 In distribution
PRO-1074-18 Length 100 mm In distribution
PRO-1024-01 Length 80 mm In distribution
SP-4204-21 Length 130 mm In distribution
PRO-1021-02 Width 20 mm In distribution
SP-4221-09 Length 160 mm In distribution
SP-4204-08 Length 150 mm In distribution
PRO-1252-03 Length 290 mm In distribution
AC01-90017 Length 140 mm In distribution
AC01-90042 In distribution
AC01-90077 Length 190 mm In distribution
PRO-1023-12 Length 190 mm In distribution
AC01-90065 In distribution
PRO-1021-21 Length 140 mm In distribution
PRO-1074-06 Length 130 mm In distribution
PRO-1074-13 Length 200 mm In distribution
PRO-1024-12 Length 190 mm In distribution
PRO-1099-08 Length 150 mm In distribution
AC01-90052 In distribution
PRO-1074-09 Length 160 mm In distribution
AC01-90082 Length 90 mm In distribution
SP-4204-01 Length 80 mm In distribution
AC01-90120 In distribution
PRO-1252-01 Length 250 mm In distribution
PRO-1074-15 Length 220 mm In distribution
PRO-1080-15 Length 220 mm In distribution
PRO-1025-03 In distribution
PRO-1265-50 Length 230 mm In distribution
PRO-1074-03 Length 100 mm In distribution
PRO-1021-11 Width 20 mm In distribution
PRO-1265-30 Width 24 mm In distribution
PRO-1265-13 Width 19 mm In distribution
AC01-90072 Length 140 mm In distribution
PRO-1265-27 Length 170 mm In distribution
AC01-90089 Length 160 mm In distribution
SP-4220-01 Length 20 mm In distribution
SP-4204-17 Length 90 mm In distribution
PRO-1265-17 Width 19 mm In distribution
AC01-90091 Length 180 mm In distribution
AC01-90078 Length 200 mm In distribution
PRO-1265-02 Length 90 mm In distribution
SP-4204-06 Length 130 mm In distribution
PRO-1024-03 Length 100 mm In distribution
PRO-1025-04 In distribution
SP-4222 In distribution
SP-4221-05 Length 120 mm In distribution
PRO-1080-07 Length 140 mm In distribution
AC01-90067 Length 90 mm In distribution
PRO-1030-02 In distribution
AC01-90086 Length 130 mm In distribution
AC01-90070 Length 120 mm In distribution
PRO-1265-11 Width 19 mm In distribution
PRO-1015-01 Width 8 mm In distribution
PRO-1265-51 Length 240 mm In distribution
PRO-1021-08 Width 20 mm In distribution
AC01-90098 In distribution
SP-4124-04 Outer Diameter 22 mm In distribution
AC01-90049 In distribution
PRO-1025-08 In distribution
SP-4122-07 Length 240 mm In distribution
PRO-1080-14 Length 210 mm In distribution
PRO-1265-03 Length 100 mm In distribution
PRO-1080-12 Length 190 mm In distribution
SP-4204-22 Length 140 mm In distribution
AC01-90109 In distribution
SP-4204-03 Length 100 mm In distribution
PRO-1021-07 Width 20 mm In distribution
PRO-1031 In distribution
PRO-1265-47 Length 200 mm In distribution
AC01-90024 Length 210 mm In distribution
SP-4221-02 Length 90 mm In distribution
AC01-90090 Length 170 mm In distribution
PRO-1265-08 Width 19 mm In distribution
SP-4204-24 Length 160 mm In distribution
PRO-1023-15 Length 220 mm In distribution
PRO-1099-09 Length 160 mm In distribution
PRO-1265-49 Length 220 mm In distribution
SP-4221-13 Length 200 mm In distribution
PRO-1099-06 Length 130 mm In distribution
AC01-90088 Length 150 mm In distribution
PRO-1265-40 Width 24 mm In distribution
PRO-1023-11 Length 180 mm In distribution
AC01-90066 Length 80 mm In distribution
PRO-1265-45 Width 24 mm In distribution
SP-4122-05 Width 8 mm In distribution
SP-4220-02 Length 30 mm In distribution
AC01-90083 Length 100 mm In distribution
PRO-1021-16 Width 30 mm In distribution
SP-4204-28 Length 200 mm In distribution
PRO-1021-09 Width 20 mm In distribution
PRO-1080-09 Length 160 mm In distribution
PRO-1099-11 Length 180 mm In distribution
PRO-1074-05 Length 120 mm In distribution
PRO-1023-05 Length 120 mm In distribution
AC01-90053 In distribution
PRO-1021-23 Width 30 mm In distribution
PRO-1021-13 Length 60 mm In distribution
PRO-1021-14 Width 30 mm In distribution
PRO-1080-01 Length 80 mm In distribution
PRO-1025-07 In distribution
PRO-1025-02 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Razek Equipamentos Razek Equipamentos Ltda 11,578
Orthopedic Manual Surgical Instrument Globus Medical, Inc. 4,784
Instrument Howmedica Osteonics Corp 4,539
Orthopedic Manual Surgical Instrument Ortho Development Corp. 4,076
Knee Instruments Medacta International SA 3,944
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 3,420
Arthrex® Arthrex, Inc. 3,106
Spine Instruments Medacta International SA 2,892
Orthopedic Manual Surgical Instrument Medtronic Sofamor Danek, Inc. 2,766
Hip Instruments Medacta International SA 1,904
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 1,756
ReLine Nuvasive, Inc. 1,208

Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument

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