Aptus

Compress. & Distract.Forceps for K-Wires

Registry build 21.09.26
53manufacturers in China registered for this device type
261catalogue 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 Aptus
Listed by Medartis Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K260761
Record published 2023-02-24
Record revised 2024-07-11 (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, manufacturing date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aptus
Catalogue number Size Status
A-2835 In distribution
A-2206 In distribution
A-2049 In distribution
A-2020 In distribution
A-2031 In distribution
A-2350 In distribution
A-7023 In distribution
A-7009 In distribution
A-2921 In distribution
A-2611 In distribution
A-2040 In distribution
A-2075 In distribution
A-2827 In distribution
A-2727.23 In distribution
A-2003 In distribution
A-2723.02 In distribution
A-2791.06 In distribution
A-2026 In distribution
A-2727.06 In distribution
A-2025 In distribution
A-7015 In distribution
A-7041 In distribution
A-2225 In distribution
A-2002.01 In distribution
A-8001.11 In distribution
A-2706 In distribution
A-7001 In distribution
A-7023 In distribution
A-7022 In distribution
A-2095.2 In distribution
A-2826 In distribution
A-2791.05 In distribution
A-2721 In distribution
A-2095.4 In distribution
A-2923.02 In distribution
A-2791.10 In distribution
A-2650 In distribution
A-7016 In distribution
A-2824 In distribution
A-2710 In distribution
A-2925 In distribution
A-7017 In distribution
A-2024 In distribution
A-7012 In distribution
A-7012 In distribution
A-2023 In distribution
A-2060 In distribution
A-7003 In distribution
A-7021 In distribution
A-2090 In distribution
A-7010 In distribution
A-2920 In distribution
A-2930 In distribution
A-2727.06 In distribution
A-2940 In distribution
A-8000.23 In distribution
A-2078 In distribution
A-2032 In distribution
A-2727.01 In distribution
A-2310 In distribution
A-2074 In distribution
A-7003 In distribution
A-2913.1 In distribution
A-2791.03 In distribution
A-2821 In distribution
A-2071 In distribution
A-2056 In distribution
A-2727.13 In distribution
A-2046 In distribution
A-2923.01 In distribution
S-02071.19 In distribution
A-2225 In distribution
A-8001.23 In distribution
A-2940 In distribution
A-7015 In distribution
A-2723.01 In distribution
A-7006 In distribution
A-7009 In distribution
A-7019 In distribution
A-2050 In distribution
A-8000.27 In distribution
A-2091.03 In distribution
A-8001.25 In distribution
A-8000.20 In distribution
A-7013 In distribution
A-8004.24 In distribution
A-2095.1 In distribution
A-2725 In distribution
A-2927 In distribution
A-2002.02 In distribution
A-2021 In distribution
A-2727.02 In distribution
A-2071 In distribution
A-2791.04 In distribution
A-2013 In distribution
A-2020 In distribution
A-8004.25 In distribution
A-2022 In distribution
A-2791.30 In distribution
A-2044 In distribution
A-2931 In distribution
A-2930 In distribution
A-2311 In distribution
A-2722 In distribution
A-8001.24 In distribution
A-2077 In distribution
A-2794 In distribution
A-2009 In distribution
A-2001.01 In distribution
A-2836 In distribution
A-2727.24 In distribution
A-2827 In distribution
A-2923.01 In distribution
A-8000.12 In distribution
A-2070 In distribution
A-7005 In distribution
A-2216 In distribution
A-2001.01 In distribution
A-2727.13 In distribution
A-2027 In distribution
A-2000 In distribution
A-7011 In distribution
A-2620 In distribution
A-2056 In distribution
A-2806 In distribution
A-2722 In distribution
A-2025 In distribution
A-8004.23 In distribution
A-2822 In distribution
A-7014 In distribution
A-2021 In distribution
A-2065 In distribution
A-2794 In distribution
A-2040 In distribution
A-2820 In distribution
A-7022 In distribution
A-2811 In distribution
A-8001.27 In distribution
A-2047 In distribution
A-2921 In distribution
A-2924 In distribution
A-2795 In distribution
A-2000 In distribution
A-2791.30 In distribution
A-2927 In distribution
A-2727.01 In distribution
A-7041 In distribution
A-7010 In distribution
A-2913.1 In distribution
A-8001.11 In distribution
A-2007 In distribution
A-8000.25 In distribution
A-2911 In distribution
A-2073 In distribution
A-7007 In distribution
A-2727.04 In distribution
A-7013 In distribution
A-2727.23 In distribution
A-2045 In distribution
A-2725 In distribution
A-8001.25 In distribution
A-7006 In distribution
A-2048 In distribution
A-2721 In distribution
A-2923.02 In distribution
A-2090 In distribution
A-2913.2 In distribution
A-2047 In distribution
A-2048 In distribution
A-8004.11 In distribution
A-2045 In distribution
A-2095.3 In distribution
A-2002.01 In distribution
A-2791.20 In distribution
A-2065 In distribution
A-2026 In distribution
A-2911 In distribution
A-2950 In distribution
A-2091.04 In distribution
A-7007 In distribution
A-2791.03 In distribution
A-2726 In distribution
A-2024 In distribution
A-2044 In distribution
A-2004 In distribution
A-2726 In distribution
A-2791.02 In distribution
A-8004.28 In distribution
A-2723.02 In distribution
A-2095.2 In distribution
A-2791.06 In distribution
A-2727.02 In distribution
A-2810 In distribution
A-2035 In distribution
A-2235 In distribution
A-7020 In distribution
A-2716 In distribution
A-2920 In distribution
A-2727.14 In distribution
A-8000.21 In distribution
A-2050 In distribution
A-2004 In distribution
A-2727.03 In distribution
A-2051 In distribution
A-7024 In distribution
A-2046 In distribution
A-2093 In distribution
A-2730 In distribution
A-2791.01 In distribution
A-2727.24 In distribution
A-8001.10 In distribution
A-8000.25 In distribution
A-2816 In distribution
A-2030 In distribution
A-2003 In distribution
A-2727.05 In distribution
A-2038 In distribution
A-2727.05 In distribution
A-2007 In distribution
A-2925 In distribution
A-2727.14 In distribution
A-7025 In distribution
A-8000.24 In distribution
A-2610 In distribution
A-2039 In distribution
A-2913.2 In distribution
A-7018 In distribution
A-8004.27 In distribution
A-2727.03 In distribution
A-8000.23 In distribution
A-2049 In distribution
A-2008 In distribution
A-2023 In distribution
A-2820 In distribution
A-2235 In distribution
A-8004.12 In distribution
A-2837 In distribution
A-2727.04 In distribution
A-2039 In distribution
A-7002 In distribution
A-2051 In distribution
A-2924 In distribution
A-2791.20 In distribution
A-2825 In distribution
A-2824 In distribution
A-2821 In distribution
A-2825 In distribution
A-2022 In distribution
A-2001.02 In distribution
A-7005 In distribution

Showing 250 of 261 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