Orthopedic › SurgicalOrthopedic Manual Surgical Instrument

iNSitu™ Hip System

Straight Side Arm, Dual Connect Offset Reamer Driver

Registry build 21.09.26
53manufacturers in China registered for this device type
86catalogue 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 iNSitu™ Hip System
Listed by Nextstep Arthropedix, United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Record published 2023-09-08
Record revised 2023-10-04 (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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for iNSitu™ Hip System
Catalogue number Size Status
10-95-3033 In distribution
10-82-3600 In distribution
10-82-4004 In distribution
10-95-2006 In distribution
10-82-0151 In distribution
10-82-3204 In distribution
10-95-2002 In distribution
10-95-2078 In distribution
10-95-3012 In distribution
10-82-2202 In distribution
10-82-0144 In distribution
10-95-2004 In distribution
10-82-0147 In distribution
10-82-2803 In distribution
10-82-3200 In distribution
10-95-2060 In distribution
10-95-2046 In distribution
10-96-0200-100 In distribution
10-82-4000 In distribution
10-82-4002 In distribution
10-95-2080 In distribution
10-82-3604 In distribution
10-82-2802 In distribution
10-96-0200 In distribution
10-82-0158 In distribution
10-82-2201 In distribution
10-95-2132 In distribution
10-82-0142 In distribution
10-95-2061 In distribution
10-96-0205 In distribution
10-95-2075 In distribution
10-82-0140 In distribution
10-82-0149 In distribution
10-96-0200-L In distribution
10-82-0148 In distribution
10-95-2034 In distribution
10-95-2047 In distribution
10-82-0143 In distribution
10-82-0153 In distribution
10-95-2032 In distribution
10-82-0160 In distribution
10-82-3601 In distribution
10-82-3203 In distribution
10-95-2030 In distribution
10-82-3602 In distribution
10-95-3007 In distribution
10-95-2003 In distribution
10-95-3000 In distribution
10-82-3202 In distribution
10-95-2074 In distribution
10-82-0154 In distribution
10-82-2800 In distribution
10-82-0155 In distribution
10-96-0200-80 In distribution
10-95-2035 In distribution
10-96-0200-60 In distribution
10-82-0159 In distribution
10-82-0152 In distribution
10-95-3009 In distribution
10-95-2005 In distribution
10-82-0157 In distribution
10-95-2029 In distribution
10-95-2027 In distribution
10-95-3032 In distribution
10-82-3603 In distribution
10-95-2036 In distribution
10-82-4001 In distribution
10-95-2001 In distribution
10-82-0141 In distribution
10-95-2031 In distribution
10-95-2059 In distribution
10-82-0139 In distribution
10-82-0156 In distribution
10-95-2079 In distribution
10-82-0150 In distribution
10-95-2065 In distribution
10-82-0146 In distribution
10-82-0145 In distribution
10-95-3035 In distribution
10-95-2033 In distribution
10-82-2801 In distribution
10-82-4003 In distribution
10-82-3201 In distribution
10-95-2077 In distribution
10-82-0138 In distribution
10-95-2076 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