Lospa IS Spinal System

DLIF cage guide sleeve inserter W22 outer sheath

Registry build 21.09.26
53manufacturers in China registered for this device type
55catalogue 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 Lospa IS Spinal System
Listed by Corentec Co., Ltd., South Korea
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-10-20
Record revised 2023-05-03 (version 2)

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, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Lospa IS Spinal System
Catalogue number Size Status
SI.C50.2114 In distribution
SI.C40.0009 In distribution
SI.C50.0110 In distribution
217100052 In distribution
212060106 In distribution
20307500 In distribution
SI.C50.0112 In distribution
217100061 In distribution
217100051 In distribution
SI.C50.0027 In distribution
20307503 In distribution
23804700 In distribution
SI.C30.0014 In distribution
SI.C40.0102 In distribution
SI.AP6.0047 In distribution
SI.C40.0004 In distribution
212060107 In distribution
217100048 In distribution
SI.C40.0102 In distribution
SI.C40.0010 In distribution
217100079 In distribution
SI.C50.0023 In distribution
SI.C50.2107 In distribution
SI.C40.0103 In distribution
SI.C50.0025 In distribution
SI.C50.2112 In distribution
808-058 In distribution
20307006 In distribution
20307502 In distribution
SI.MP6.0014 In distribution
20308301 In distribution
217100058 In distribution
SI.C50.0111 In distribution
SI.C50.2110 In distribution
SI.C50.0109 In distribution
SI.C40.0003 In distribution
SI.C50.0114 In distribution
SI.C50.0113 In distribution
217100039 In distribution
SI.C50.2111 In distribution
SI.C40.0100 In distribution
217100060 In distribution
SI.C50.0108 In distribution
SI.MP6.0021 In distribution
SI.AP6.0057 In distribution
217100049 In distribution
217100057 In distribution
SI.C50.2113 In distribution
SI.C50.2108 In distribution
217100050 In distribution
21805001 In distribution
SI.C50.0107 In distribution
217100059 In distribution
SI.AP6.0052 In distribution
SI.C50.2109 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