Trigen

13.5MM Deep Fluted Cutting Reamer Head

Registry build 21.09.26
23manufacturers in China registered for this device type
1,029catalogue 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 Trigen
Listed by Smith & Nephew, Inc., United States
FDA product code HTO
Device type Reamer
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-05-27
Record revised 2023-10-04 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Trigen
Catalogue number Size Status
E0017726-12 In distribution
E0017293-15 In distribution
E0017037-14 In distribution
E0017728-15 In distribution
E0017043-1 In distribution
E0017886-1 In distribution
E0017299-15 In distribution
E0017300-3 In distribution
E0017180-10 In distribution
E0017129-2 In distribution
E0017484-9 In distribution
E0018149-8 In distribution
E0016892-1 In distribution
E0017959-3 In distribution
E0017501-6 In distribution
E0017299-1 In distribution
E0017407-10 In distribution
E0017908-5 In distribution
E0018299-11 In distribution
E0018223-5 In distribution
E0017300-4 In distribution
E0017299-7 In distribution
E0017732-13 In distribution
E0018087-3 In distribution
E0017501-9 In distribution
E0017484-1 In distribution
E0017705-1 In distribution
E0017728-12 In distribution
E0017791-3 In distribution
E0017871-2 In distribution
E0017787-2 In distribution
E0017650-14 In distribution
E0018089-1 In distribution
E0017675-2 In distribution
E0017832-11 In distribution
E0017490-10 In distribution
E0017419-5 In distribution
E0016362-1 In distribution
E0017331-10 In distribution
E0018149-9 In distribution
E0017225-7 In distribution
E0016912-7 In distribution
E0017312-11 In distribution
E0017787-15 In distribution
E0017037-13 In distribution
E0015780-4 In distribution
E0018224-1 In distribution
E0017312-9 In distribution
E0016911-7 In distribution
E0015780-13 In distribution
E0017331-1 In distribution
E0018090-13 In distribution
E0017419-8 In distribution
E0017484-2 In distribution
E0018047-5 In distribution
E0017567-13 In distribution
E0017675-1 In distribution
E0017567-12 In distribution
E0018047-11 In distribution
E0018149-4 In distribution
E0017023-1 In distribution
E0017312-8 In distribution
E0017890-1 In distribution
E0017706-8 In distribution
E0018086-1 In distribution
E0017708-14 In distribution
E0017312-14 In distribution
E0017331-9 In distribution
E0017300-7 In distribution
E0017830-4 In distribution
E0017847-2 In distribution
E0017522-1 In distribution
E0017886-4 In distribution
E0017358-1 In distribution
E0017490-9 In distribution
E0017494-15 In distribution
E0016910-7 In distribution
E0017005-15 In distribution
E0017787-8 In distribution
E0017300-2 In distribution
E0017312-13 In distribution
E0017719-11 In distribution
E0017828-3 In distribution
E0017028-1 In distribution
E0017908-10 In distribution
E0016000-4 In distribution
E0017726-14 In distribution
E0018297-1 In distribution
E0017385-4 In distribution
E0018149-6 In distribution
E0017927-2 In distribution
E0017501-2 In distribution
E0018299-7 In distribution
E0016911-1 In distribution
E0017719-7 In distribution
E0017642-1 In distribution
E0017726-1 In distribution
E0018089-3 In distribution
E0017719-5 In distribution
E0017331-14 In distribution
E0017501-10 In distribution
E0018047-7 In distribution
E0016884-10 In distribution
E0016000-10 In distribution
E0017331-3 In distribution
E0017485-5 In distribution
E0016418-1 In distribution
E0018089-2 In distribution
E0017830-5 In distribution
E0017005-12 In distribution
E0017954-5 In distribution
E0017501-13 In distribution
E0017603-1 In distribution
E0018229-2 In distribution
E0017753-3 In distribution
E0018259-1 In distribution
E0017826-6 In distribution
E0017490-7 In distribution
E0017632-5 In distribution
E0018087-6 In distribution
E0017728-10 In distribution
E0017180-9 In distribution
E0017706-5 In distribution
E0016910-3 In distribution
E0017732-6 In distribution
E0017928-12 In distribution
E0017832-9 In distribution
E0017673-14 In distribution
E0017225-14 In distribution
E0018299-6 In distribution
E0017180-11 In distribution
E0017300-13 In distribution
E0018299-5 In distribution
E0017728-13 In distribution
E0016364-1 In distribution
E0016956-3 In distribution
E0017928-14 In distribution
E0016884-7 In distribution
E0018223-12 In distribution
E0017719-9 In distribution
E0017829-3 In distribution
E0017829-2 In distribution
E0016884-2 In distribution
E0017129-5 In distribution
E0017005-3 In distribution
E0017706-6 In distribution
E0016847-1 In distribution
E0018032-2 In distribution
E0017673-7 In distribution
E0017832-8 In distribution
E0017708-6 In distribution
E0017728-4 In distribution
E0016911-5 In distribution
E0017829-6 In distribution
E0017485-14 In distribution
E0018089-12 In distribution
E0017300-8 In distribution
E0017705-4 In distribution
E0017673-12 In distribution
E0016911-3 In distribution
E0017831-13 In distribution
E0016892-14 In distribution
E0017927-8 In distribution
E0017959-6 In distribution
E0017312-6 In distribution
E0017407-2 In distribution
E0017706-14 In distribution
E0016911-6 In distribution
E0017832-5 In distribution
E0017847-15 In distribution
E0017871-13 In distribution
E0018000-2 In distribution
E0018304-2 In distribution
E0018090-4 In distribution
E0017485-9 In distribution
E0017632-4 In distribution
E0017708-15 In distribution
E0017407-4 In distribution
E0017501-11 In distribution
E0017331-12 In distribution
E0017485-10 In distribution
E0017708-10 In distribution
E0017871-4 In distribution
E0017705-8 In distribution
E0018149-5 In distribution
E0017705-6 In distribution
E0017908-1 In distribution
E0017407-12 In distribution
E0017485-11 In distribution
E0017494-10 In distribution
E0018080-2 In distribution
E0016702-1 In distribution
E0017705-13 In distribution
E0017817-1 In distribution
E0016892-6 In distribution
E0018089-5 In distribution
E0016912-8 In distribution
E0017225-6 In distribution
E0018089-10 In distribution
E0017719-12 In distribution
E0017928-1 In distribution
E0017005-16 In distribution
E0017650-5 In distribution
E0017100-2 In distribution
E0017706-9 In distribution
E0017180-5 In distribution
E0017632-3 In distribution
E0017954-3 In distribution
E0018299-9 In distribution
E0017485-12 In distribution
E0016884-15 In distribution
E0017719-1 In distribution
E0016000-11 In distribution
E0017501-8 In distribution
E0017954-9 In distribution
E0017180-4 In distribution
E0017726-4 In distribution
E0017725-1 In distribution
E0017954-8 In distribution
E0016000-9 In distribution
E0016912-1 In distribution
E0017567-9 In distribution
E0017847-4 In distribution
E0017005-11 In distribution
E0017954-12 In distribution
E0017312-15 In distribution
E0017708-9 In distribution
E0017299-12 In distribution
E0017908-11 In distribution
E0017928-10 In distribution
E0017826-9 In distribution
E0017494-11 In distribution
E0017927-7 In distribution
E0017485-15 In distribution
E0018149-3 In distribution
E0017035-3 In distribution
E0016704-1 In distribution
E0017650-12 In distribution
E0017830-12 In distribution
E0017832-13 In distribution
E0017490-11 In distribution
E0018089-9 In distribution
E0017707-15 In distribution
E0018299-12 In distribution
E0016131-1 In distribution
E0017708-1 In distribution
E0017871-15 In distribution
E0017005-9 In distribution
E0018299-14 In distribution
E0017871-10 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Arthrex Provision 98

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