Primus

1.5mm X 24in Nitinol K-Wire, Thd Trocar

Registry build 21.09.26
53manufacturers in China registered for this device type
69catalogue 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 Primus
Listed by Spinal Elements, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2026-01-16

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

Catalogue Numbers

Catalogue numbers for Primus
Catalogue number Size Status
66540-060 In distribution
66540-085 In distribution
66541-080 In distribution
66541-065 In distribution
66545-050 In distribution
66541-090 In distribution
66546-105 In distribution
66430-124 In distribution
66541-070 In distribution
66541-055 In distribution
66540-065 In distribution
66430-218 In distribution
66540-105 In distribution
66435-224 In distribution
66435-218 In distribution
66546-090 In distribution
66540-070 In distribution
66546-060 In distribution
66027-130 In distribution
66430-324 In distribution
66546-050 In distribution
66545-070 In distribution
66546-095 In distribution
66430-018 In distribution
66540-090 In distribution
66540-080 In distribution
66027-060 In distribution
66545-090 In distribution
66540-040 In distribution
66430-224 In distribution
66541-095 In distribution
66545-075 In distribution
66541-045 In distribution
66546-065 In distribution
66435-018 In distribution
66541-060 In distribution
66541-045 In distribution
66541-085 In distribution
66023-055-040 In distribution
66435-118 In distribution
66541-075 In distribution
66546-070 In distribution
66540-050 In distribution
66546-085 In distribution
66430-118 In distribution
66545-105 In distribution
66435-024 In distribution
66435-318 In distribution
66545-045 In distribution
66540-055 In distribution
66545-080 In distribution
66540-075 In distribution
66435-124 In distribution
66451-000 In distribution
66545-065 In distribution
66541-105 In distribution
66540-095 In distribution
66435-324 In distribution
66430-318 In distribution
66430-024 In distribution
66545-085 In distribution
66546-045 In distribution
66545-095 In distribution
66541-040 In distribution
66545-060 In distribution
66546-055 In distribution
66546-080 In distribution
66540-045 In distribution
66546-075 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