UNI-Thread®

Pedicle Markers for 7.5mm Connectors

Registry build 21.09.26
53manufacturers in China registered for this device type
77catalogue 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 UNI-Thread®
Listed by Spinevision SAS, France
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2015-10-21
Record revised 2025-01-10 (version 3)

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

Catalogue Numbers

Catalogue numbers for UNI-Thread®
Catalogue number Size Status
L2-ALIS411US 0 In distribution
L2-ALIS751-50 0 In distribution
L2-A307 0 In distribution
L2-ALIS717R 0 In distribution
L2-A333 0 In distribution
L2-A203 Diameter: 3 Milliimeters, Length: 70 Milliimeters In distribution
L2-ALIS701R 0 In distribution
L2-ALIS745 0 In distribution
L2-A534 0 In distribution
L2-A312 0 In distribution
L2-A201 Diameter: 3 Milliimeters, Length: 50 Milliimeters In distribution
L2-ALIS716L Length: 60 Milliimeters In distribution
L2-A314 0 In distribution
L2-A533N2 0 In distribution
L2-ALIS748 0 In distribution
L2-ALIS741-4 0 In distribution
L2-A313 0 In distribution
L2-ALIS715R Length: 50 Milliimeters In distribution
L2-A418 0 In distribution
L2-ALIS753 Diameter: 9,5 Milliimeters In distribution
L2-ALIS704 0 In distribution
L2-A339 0 In distribution
L2ASPL002 0 In distribution
L2-ALIS715L Length: 50 Milliimeters In distribution
L2-ALIS747 0 In distribution
L2-ASPL008 Diameter: 7,5 Milliimeters In distribution
L2-ALIS703 0 In distribution
L2-ALIS750 0 In distribution
L2-ALIS740 0 In distribution
L2-ASPL009 Diameter: 7,5 Milliimeters In distribution
L2-A411 0 In distribution
L2-ALIS716R Length: 60 Milliimeters In distribution
L2ASPL005 0 In distribution
L2ASPL007 0 In distribution
L2ASPL003 0 In distribution
L2-ALIS743 0 In distribution
L2-A416 0 In distribution
L2-ALIS702R 0 In distribution
L2-ALIS 702L 0 In distribution
L2-ALIS741-2 0 In distribution
L2-A336 0 In distribution
L2-A535 0 In distribution
L2-A204 Diameter: 4 Milliimeters, Length: 60 Milliimeters In distribution
L2-A202 Diameter: 3 Milliimeters, Length: 60 Milliimeters In distribution
L2-ALIS211US Diameter: 1,8 Milliimeters, Length: 510 Milliimeters In distribution
L2-A310 0 In distribution
L2-ALIS757 0 In distribution
L2-A335N1 0 In distribution
L2ASPL004 0 In distribution
L2-ALIS754 0 In distribution
L2-ALIS741-1 0 In distribution
L2-ALIS717L Length: 70 Milliimeters In distribution
L2-A410N1 0 In distribution
L2-ALIS701L 0 In distribution
L2-ALIS211 Diameter: 1,8 Milliimeters, Length: 510 Milliimeters In distribution
L2-A305 0 In distribution
L2ASPL001 0 In distribution
L2-A534N1 0 In distribution
L2-A410 0 In distribution
U1-A620 0 In distribution
L2-ALIS751-70 0 In distribution
L2-A533 0 In distribution
L2-ALIS741 0 In distribution
L2-A335 0 In distribution
L2-A306 0 In distribution
L2-ALIS751-90 0 In distribution
L2-ALIS741-3 0 In distribution
L2-A533N1 0 In distribution
L2-A304 0 In distribution
L2-ALIS534 0 In distribution
L2-ALIS 411 0 In distribution
L2-ASPL011 0 In distribution
L2-ALIS741-5 0 In distribution
L2ASPL006 0 In distribution
L2-ALIS210 Diameter: 1,8 Milliimeters In distribution
L2-ALIS749 0 In distribution
L2-ALIS533 0 In distribution

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