Shoulder System Instrument

Shoulder System - Anatomic instr. tray - 2 levels

Registry build 21.09.26
53manufacturers in China registered for this device type
324catalogue 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 Shoulder System Instrument
Listed by Medacta International SA, Switzerland
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-05-18

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Shoulder System Instrument
Catalogue number Size Status
04.01.10.0054 In distribution
04.01.10.0177 In distribution
04.01.10.0172 In distribution
04.01.10.0559 In distribution
04.01.10.0134 In distribution
04.01.10.0189 In distribution
04.01.10.0147 In distribution
04.01.10.0190 In distribution
04.01.10.0014 In distribution
04.01.10.0149 In distribution
04.01.10.0269 In distribution
04.01.10.0219 In distribution
04.01.10.0183 In distribution
04.01.10.0185 In distribution
04.01.10.0064 In distribution
04.01.10.0044 In distribution
04.01.10.0240 In distribution
04.01.10.0427 In distribution
04.01.10.1199 In distribution
04.01.10.0146 In distribution
04.01.10.0017 In distribution
04.01.10.0232 In distribution
04.01.10.0027 In distribution
04.01.10.0188 In distribution
04.01.10.0681 In distribution
04.01.10.1195 In distribution
04.01.10.0169 In distribution
04.01.10.0028 In distribution
04.01.10.0104 In distribution
04.01.10.0198 In distribution
04.01.10.0231 In distribution
04.01.10.0070 In distribution
04.01.10.0195 In distribution
04.01.10.0257 In distribution
04.01.10.1194 In distribution
04.01.10.0078 In distribution
04.01.10.0264 In distribution
04.01.10.0214 In distribution
04.01.10.1200 In distribution
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04.01.10.0016 In distribution
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04.01.10.0060 In distribution
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04.01.10.0178 In distribution
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04.01.10.0077 In distribution
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04.01.10.0138 In distribution
04.01.10.0079 In distribution
04.01.10.0123 In distribution
04.01.10.0152 In distribution
04.01.10.9009 In distribution
04.01.10.0428 In distribution
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04.01.10.0153 In distribution
04.01.10.0076 In distribution
04.01.10.0281 In distribution
04.01.10.0031 In distribution
04.01.10.0201 In distribution
04.01.10.0058 In distribution
04.01.10.0560 In distribution
04.01.10.0035 In distribution
04.01.10.0136 In distribution
04.01.10.0139 In distribution
04.01.10.9007 In distribution
04.01.10.0066 In distribution
04.01.10.0128 In distribution
04.01.10.0050 In distribution
04.01.10.0008 In distribution
04.01.10.0161 In distribution
04.01.10.0270 In distribution
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04.01.10.0013 In distribution
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04.01.10.0171 In distribution
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04.01.10.0557 In distribution
04.01.10.0080 In distribution
04.01.10.0020 In distribution
04.01.10.0211 In distribution
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04.01.10.0072 In distribution
04.01.10.0115 In distribution
04.01.10.0090 In distribution
04.01.10.0279 In distribution
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04.01.10.0092 In distribution
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04.01.10.0021 In distribution
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04.01.10.0218 In distribution
04.01.10.1198 In distribution
04.01.10.9006 In distribution
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04.01.10.0272H In distribution
04.01.10.0075 In distribution
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04.01.10.0007 In distribution
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04.01.10.0059 In distribution
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04.01.10.0024 In distribution
04.01.10.0026 In distribution
04.01.10.0244 In distribution
04.01.10.0176 In distribution
04.01.10.0102 In distribution
04.01.10.1193 In distribution
04.01.10.0062 In distribution
04.01.10.0556 In distribution
04.01.10.0107 In distribution
04.01.10.0259 In distribution
04.01.10.0210 In distribution
04.01.10.0133 In distribution
04.01.10.0125 In distribution
04.01.10.0085 In distribution
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04.01.10.0055 In distribution
04.01.10.0263 In distribution
04.01.10.1191 In distribution
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04.01.10.0006 In distribution
04.01.10.0173 In distribution
04.01.10.0101 In distribution
04.01.10.0159 In distribution
04.01.10.0019 In distribution
04.01.10.0130 In distribution
04.01.10.0003 In distribution
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04.01.10.0429 In distribution
04.01.10.0223 In distribution
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04.01.10.0260 In distribution
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04.01.10.0057 In distribution
04.01.10.0132 In distribution
04.01.10.0682 In distribution
04.01.10.0166 In distribution
04.01.10.0287 In distribution
04.01.10.0558 In distribution
04.01.10.0065 In distribution
04.01.10.0037 In distribution
04.01.10.0271 In distribution
04.01.10.0097 In distribution
04.01.10.0158 In distribution
04.01.10.0110 In distribution
04.01.10.0001 In distribution
04.01.10.0175 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