General Instruments

Silicone Handle, Large Tapered Axial, NON-Ratcheting 1/4" SQ., Cannulated, Impacting

Registry build 21.09.26
53manufacturers in China registered for this device type
346catalogue 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 General Instruments
Listed by Alphatec Spine, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2024-11-18
Record revised 2025-07-14 (version 3)

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for General Instruments
Catalogue number Size Status
CI-11596 In distribution
CI-10215-41 In distribution
67200-020 In distribution
CI-10215-40 In distribution
CI-11376 In distribution
CI-11824 In distribution
CI-10376 In distribution
CI-10048-01 In distribution
CI-10238-200 In distribution
CI-11482 In distribution
CI-10635 In distribution
CI-10566 In distribution
CI-11923-200 In distribution
CI-10705-100 In distribution
CI-11619-1806 In distribution
CI-11923-165 In distribution
CI-11405 In distribution
CI-10215-10 In distribution
CI-11311-08 In distribution
CI-11585 In distribution
86903-0600-090 In distribution
CI-11755-30 In distribution
CI-10599-10 In distribution
CI-11369 In distribution
CI-11705 In distribution
CI-11383-01 In distribution
CI-10921-01 In distribution
CI-10180-1400 In distribution
CI-11971 In distribution
CI-10599-20 In distribution
CI-11358 In distribution
CI-10271-10 In distribution
CI-10821 In distribution
CI-10508 In distribution
CI-10293-10 In distribution
CI-10662 In distribution
CI-11791 In distribution
CI-11904 In distribution
CI-10681-2 In distribution
CI-11656 In distribution
CI-11699 In distribution
CI-11559-02 In distribution
CI-11325 In distribution
CI-10279 In distribution
CI-10623-20 In distribution
CI-11842 In distribution
CI-10663 In distribution
86013-1200-080 In distribution
CI-10215-20 In distribution
CI-11957 In distribution
86013-1200-060 In distribution
CI-11843-08 In distribution
CI-10209 In distribution
CI-10711 In distribution
CI-11370 In distribution
CI-10758 In distribution
CI-10647 In distribution
CI-11383-02 In distribution
CI-10088 In distribution
CI-10738 In distribution
CI-11624 In distribution
CI-11793 In distribution
CI-10847-200-15 In distribution
CI-10272 In distribution
CI-10194-1400 In distribution
CI-10180-1200 In distribution
CI-10180-0810 In distribution
CI-10838-01-01 In distribution
CI-11542 In distribution
CI-11215-30 In distribution
CI-11012-02 In distribution
CI-10743 In distribution
CI-11330-50 In distribution
CI-10180-1210 In distribution
CI-11785 In distribution
CI-10675 In distribution
CI-11687 In distribution
CI-11983-300 In distribution
CI-10194-0810 In distribution
CI-11225-40 In distribution
CI-11502 In distribution
CI-10681-1 In distribution
CI-11872-300 In distribution
CI-10308 In distribution
67200-100 In distribution
CI-11872-200 In distribution
CI-11913 In distribution
CI-10681-4 In distribution
CI-11605-10 In distribution
CI-11540 In distribution
CI-11559-03 In distribution
CI-10579-20 In distribution
CI-11291-300-22-1 In distribution
CI-11872-100 In distribution
CI-11332-02 In distribution
CI-10044 In distribution
CI-10071 In distribution
CI-11896 In distribution
CI-10440 In distribution
CI-10246-03 In distribution
CI-11236-30 In distribution
CI-11875-1 In distribution
CI-10590 In distribution
CI-11012-01 In distribution
CI-11318 In distribution
CI-11100 In distribution
CI-11755-20 In distribution
CI-10483 In distribution
CI-11849 In distribution
CI-11863 In distribution
CI-10636-20 In distribution
CI-10101-01 In distribution
CI-11856 In distribution
CI-10234 In distribution
CI-10746-30 In distribution
CI-10636-10 In distribution
CI-11469-100 In distribution
86073-1101 In distribution
CI-10048 In distribution
CI-11788 In distribution
CI-11398 In distribution
CI-11667-1000 In distribution
CI-11869-10 In distribution
CI-11441 In distribution
CI-10634-10 In distribution
CI-11347 In distribution
CI-11568-03 In distribution
CI-10847-06-04 In distribution
CI-11979 In distribution
CI-11332-01 In distribution
CI-11899 In distribution
CI-11895-300-45 In distribution
CI-10107 In distribution
CI-10708 In distribution
CI-10215-42 In distribution
CI-11924 In distribution
CI-10246 In distribution
CI-10396 In distribution
CI-11541 In distribution
CI-11755-25 In distribution
CI-11407 In distribution
CI-11994-02 In distribution
CI-10362 In distribution
CI-11914-27-2 In distribution
CI-10140 In distribution
CI-11635 In distribution
CI-11287 In distribution
CI-11337-100 In distribution
CI-10191 In distribution
CI-11887 In distribution
CI-10874 In distribution
CI-11734-R In distribution
CI-10194-1210 In distribution
CI-10150-200 In distribution
CI-11483-550-01 In distribution
CI-10236-35 In distribution
CI-10592 In distribution
CI-11727 In distribution
CI-11568 In distribution
CI-11328 In distribution
CI-11946 In distribution
CI-11253 In distribution
CI-11430 In distribution
CI-10143 In distribution
CI-10150-100 In distribution
CI-10714-1 In distribution
CI-11291-300-26-1 In distribution
CI-10724 In distribution
CI-10180-1410 In distribution
CI-11667-0800 In distribution
CI-11632-06 In distribution
CI-10838-02-01 In distribution
CI-10101-03 In distribution
CI-10197-20 In distribution
CI-11941 In distribution
CI-11668 In distribution
CI-10512-1 In distribution
CI-10101-02 In distribution
CI-10626 In distribution
CI-11379 In distribution
CI-10484 In distribution
CI-10229 In distribution
CI-10173 In distribution
CI-10264 In distribution
CI-11876 In distribution
CI-10737-01 In distribution
CI-11922-12 In distribution
CI-10101 In distribution
CI-11338 In distribution
CI-11983-100 In distribution
CI-11245-20 In distribution
CI-10694 In distribution
CI-11424-03-100 In distribution
CI-11245-10 In distribution
67200-015 In distribution
CI-11337-200 In distribution
CI-10905 In distribution
CI-11013 In distribution
CI-11787 In distribution
CI-10838-01-02 In distribution
CI-11659 In distribution
CI-11225-30-10 In distribution
CI-10236-25 In distribution
CI-11300-20 In distribution
CI-11420 In distribution
CI-10103-2 In distribution
CI-11225-30-20 In distribution
CI-11483-550-02 In distribution
CI-11817-560 In distribution
CI-11357-14 In distribution
67200-000 In distribution
CI-11838 In distribution
CI-10353 In distribution
CI-10197-10 In distribution
CI-11618 In distribution
CI-11779 In distribution
CI-10070 In distribution
CI-11942 In distribution
CI-11822-P In distribution
CI-10048-03 In distribution
CI-10438 In distribution
CI-11471 In distribution
CI-10194-1200 In distribution
CI-11488 In distribution
CI-11910-02 In distribution
CI-11357-10 In distribution
CI-10235-20 In distribution
CI-11236-20 In distribution
CI-11983-910 In distribution
CI-10235-10 In distribution
CI-11259-550-01 In distribution
CI-11595 In distribution
CI-10214 In distribution
CI-11902 In distribution
CI-11478 In distribution
CI-11910-01 In distribution
CI-11260 In distribution
CI-10180-0800 In distribution
CI-11442 In distribution
CI-10441 In distribution
CI-10339 In distribution
CI-10709 In distribution
CI-11225 In distribution
CI-11021 In distribution
CI-10847-06-06 In distribution
CI-11469-200 In distribution
CI-10194-1000 In distribution
86903-0600-080 In distribution
CI-10280-20 In distribution
CI-10393-03 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