Razor Single-Use Acetabular Reamer

Acetabular Orthopedic Reamer, 59mm

Registry build 21.09.26
23manufacturers in China registered for this device type
36catalogue 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 Razor Single-Use Acetabular Reamer
Listed by Razor Medical Instruments, Inc.
FDA product code HTO
Device type Reamer
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2023-01-08
Record revised 2023-10-04 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date
Sizes Outer diameter 46 to 66 mm

Catalogue Numbers

Catalogue numbers for Razor Single-Use Acetabular Reamer
Catalogue number Size Status
1000-0059 Outer Diameter 59 mm In distribution
1000-0048 Outer Diameter 48 mm In distribution
1001-0063 Outer Diameter 63 mm In distribution
1000-0053 Outer Diameter 53 mm In distribution
1000-0049 Outer Diameter 49 mm In distribution
1000-0055 Outer Diameter 55 mm In distribution
1001-0051 Outer Diameter 51 mm In distribution
1001-0060 Outer Diameter 60 mm In distribution
1001-0046 Outer Diameter 46 mm In distribution
1001-0061 Outer Diameter 61 mm In distribution
1001-0053 Outer Diameter 53 mm In distribution
1001-0058 Outer Diameter 58 mm In distribution
1000-0047 Outer Diameter 47 mm In distribution
1000-0051 Outer Diameter 51 mm In distribution
1001-0064 Outer Diameter 64 mm In distribution
1000-0057 Outer Diameter 57 mm In distribution
1000-0052 Outer Diameter 52 mm In distribution
1000-0058 Outer Diameter 58 mm In distribution
1001-0062 Outer Diameter 62 mm In distribution
1001-0049 Outer Diameter 49 mm In distribution
1001-0048 Outer Diameter 48 mm In distribution
1001-0055 Outer Diameter 55 mm In distribution
1000-0050 Outer Diameter 50 mm In distribution
1001-0059 Outer Diameter 59 mm In distribution
1000-0054 Outer Diameter 54 mm In distribution
1001-0052 Outer Diameter 52 mm In distribution
1000-0046 Outer Diameter 46 mm In distribution
1000-0060 Outer Diameter 60 mm In distribution
1001-0056 Outer Diameter 56 mm In distribution
1001-0054 Outer Diameter 54 mm In distribution
1001-0065 Outer Diameter 65 mm In distribution
1000-0056 Outer Diameter 56 mm In distribution
1001-0066 Outer Diameter 66 mm In distribution
1001-0047 Outer Diameter 47 mm In distribution
1001-0050 Outer Diameter 50 mm In distribution
1001-0057 Outer Diameter 57 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