LexTOME

LexTOME Acetabular Reamer 40mm

Registry build 21.09.26
23manufacturers in China registered for this device type
46catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (6), Zhejiang (3). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTO
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
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
Changzhou Master Precision Tool Co., Ltd. Changzhou Jiangsu Contract manufacturer 3
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38

Showing 12 of 23. All 23 manufacturers in China registered for Reamer

Record

Regulatory record for LexTOME
Listed by Medmetalex Co., Ltd., Japan
FDA product code HTO
Device type Reamer
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2023-04-17

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number
Sizes Outer diameter 36 to 80 mm; outer diameter 77 µm

Catalogue Numbers

Catalogue numbers for LexTOME
Catalogue number Size Per pack Status
MUA00034 Outer Diameter 69 mm In distribution
MUA00003 Outer Diameter 38 mm In distribution
MUA00031 Outer Diameter 66 mm In distribution
MUA00028 Outer Diameter 63 mm In distribution
MUA00045 Outer Diameter 80 mm In distribution
MUA00012 Outer Diameter 47 mm In distribution
MUA00011 Outer Diameter 46 mm In distribution
MUA00002 Outer Diameter 37 mm In distribution
MUA00029 Outer Diameter 64 mm In distribution
MUA00019 Outer Diameter 54 mm In distribution
MUA00036 Outer Diameter 71 mm In distribution
MUA00017 Outer Diameter 52 mm In distribution
MUA00004 Outer Diameter 39 mm In distribution
MUA00044 Outer Diameter 79 mm In distribution
MUA00027 Outer Diameter 62 mm In distribution
MUA00007 Outer Diameter 42 mm In distribution
MUA00006 Outer Diameter 41 mm In distribution
MUA00038 Outer Diameter 73 mm In distribution
MUA00001 Outer Diameter 36 mm In distribution
MUA00049 30 In distribution
MUA00030 Outer Diameter 65 mm In distribution
MUA00021 Outer Diameter 56 mm In distribution
MUA00039 Outer Diameter 74 mm In distribution
MUA00023 Outer Diameter 58 mm In distribution
MUA00032 Outer Diameter 67 mm In distribution
MUA00043 Outer Diameter 78 mm In distribution
MUA00016 Outer Diameter 51 mm In distribution
MUA00040 Outer Diameter 75 mm In distribution
MUA00013 Outer Diameter 48 mm In distribution
MUA00033 Outer Diameter 68 mm In distribution
MUA00037 Outer Diameter 72 mm In distribution
MUA00014 Outer Diameter 49 mm In distribution
MUA00020 Outer Diameter 55 mm In distribution
MUA00008 Outer Diameter 43 mm In distribution
MUA00018 Outer Diameter 53 mm In distribution
MUA00015 Outer Diameter 50 mm In distribution
MUA00024 Outer Diameter 59 mm In distribution
MUA00025 Outer Diameter 60 mm In distribution
MUA00026 Outer Diameter 61 mm In distribution
MUA00005 Outer Diameter 40 mm In distribution
MUA00010 Outer Diameter 45 mm In distribution
MUA00009 Outer Diameter 44 mm In distribution
MUA00022 Outer Diameter 57 mm In distribution
MUA00042 Outer Diameter 77 µm In distribution
MUA00035 Outer Diameter 70 mm In distribution
MUA00041 Outer Diameter 76 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Trigen Smith & Nephew, Inc. 1,029
Viant Medical, LLC Viant Medical, LLC 825
R3 Smith & Nephew, Inc. 287
Reamer Ortho Development Corp. 259
InSitu Hip System Nextstep Arthropedix 181
Apex Knee System Omni Life Science, Inc. 162
Reamer Synthes Gmbh 152
Reclaim Depuy (Ireland) 138
Reamer Zimmer, Inc. 135
Endo-Model Knee System – Instruments Waldemar Link GmbH & Co. KG 109
DJO Surgical Encore Medical, L.P. 108
Arthrex® Arthrex, Inc. 105

Showing 12 of 1,224. All products under Reamer

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