MaxFuse PEEK VBR System

MAXFUSE, 14.5x17x4850 REPLICA TRL SPACER

Registry build 21.09.26
21manufacturers in China registered for this device type
40catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWT
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
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 Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5
Guangzhou Clean Medical Products Manufacturing Corp Guangzhou Guangdong Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 21. All 21 manufacturers in China registered for Template

Record

Regulatory record for MaxFuse PEEK VBR System
Listed by Rti Surgical, Inc., United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Premarket notification Exempt
Record published 2020-09-25
Record revised 2023-10-19 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for MaxFuse PEEK VBR System
Catalogue number Size Status
724-840 In distribution
724-841 In distribution
724-432 In distribution
724-832 In distribution
724-835 In distribution
724-846 In distribution
724-845 In distribution
724-900 In distribution
724-849 In distribution
724-829 In distribution
724-903 In distribution
724-828 In distribution
724-899 In distribution
724-831 In distribution
724-837 In distribution
724-848 In distribution
724-588 In distribution
724-585 In distribution
724-904 In distribution
724-584 In distribution
724-433 In distribution
724-830 In distribution
724-902 In distribution
724-429 In distribution
724-907 In distribution
724-827 In distribution
724-833 In distribution
724-843 In distribution
724-431 In distribution
724-430 In distribution
724-906 In distribution
724-905 In distribution
724-838 In distribution
724-586 In distribution
724-587 In distribution
724-839 In distribution
724-836 In distribution
724-844 In distribution
724-901 In distribution
724-847 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Attune Depuy (Ireland) 1,385
Template Exactech, Inc. 1,277
4WEB Medical 4WEB Inc. 991
Evolution® Microport Orthopedics Inc. 966
Template Zimmer, Inc. 792
Advance® Microport Orthopedics Inc. 644
Apex Knee System Omni Life Science, Inc. 635
Profemur® Microport Orthopedics Inc. 591
Link Instruments – Trial implants and size gauges Waldemar Link GmbH & Co. KG 549
Template Synthes Gmbh 516
Optetrak Logic Exactech, Inc. 512
Template Depuy Spine, Inc. 451

Showing 12 of 2,940. All products under Template

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