Legion

Legion REV Monoblock Constrained Insert Trial W/Jrny Lock SZ 5-6 11MM

Registry build 21.09.26
21manufacturers in China registered for this device type
179catalogue 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 Legion
Listed by Smith & Nephew, Inc., United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2021-02-05
Record revised 2023-09-07 (version 4)

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

Catalogue Numbers

Catalogue numbers for Legion
Catalogue number Size Status
71434614 In distribution
E0016590-2 In distribution
71435322 In distribution
71434618 In distribution
71434635 In distribution
71434622 In distribution
71430042 Left: Left In distribution
71430041 Left: Left In distribution
E0015858-1 In distribution
71430051 Right: Right In distribution
E0017710-14 In distribution
71434601 In distribution
71434602 In distribution
E0017282-1 In distribution
E0017765-6 In distribution
71430302 Left: Left In distribution
71435301 In distribution
E0017710-13 In distribution
71434626 In distribution
71435317 In distribution
71430308 Size 7-8: Size 7-8 In distribution
71434605 In distribution
71935889 In distribution
E0016590-3 In distribution
71430047 Size 7-8: Size 7-8 In distribution
71935888 In distribution
71435316 In distribution
71430046 Left: Left In distribution
71434607 In distribution
71434617 In distribution
71935890 In distribution
71434608 In distribution
71430048 Size 7-8: Size 7-8 In distribution
71935891 In distribution
E0016743-12 In distribution
71430307 Left: Left In distribution
71430314 Right: Right In distribution
71435337 In distribution
E0017680-11 In distribution
71435321 In distribution
71435307 In distribution
71434624 In distribution
71434616 In distribution
E0016590-6 In distribution
E0017710-2 In distribution
71435327 In distribution
71430049 Right: Right In distribution
E0017710-15 In distribution
71433101 In distribution
71434613 In distribution
71435323 In distribution
E0015422-1 In distribution
E0017765-1 In distribution
E0016590-4 In distribution
71435334 In distribution
71430317 Size 7-8: Size 7-8 In distribution
E0017710-4 In distribution
71434611 In distribution
71435336 In distribution
71430306 Left: Left In distribution
71430301 Size 1-2: Size 1-2 In distribution
E0017710-11 In distribution
71935886 In distribution
71435338 In distribution
E0015698-1 In distribution
71435324 In distribution
71433107 In distribution
71430053 Right: Right In distribution
71433113 In distribution
E0016711-1 In distribution
E0018279-2 In distribution
E0016710-1 In distribution
E0016116-2 In distribution
71433119 In distribution
71435304 In distribution
71430315 Right: Right In distribution
71430305 Size 5-6: Size 5-6 In distribution
71433109 In distribution
E0017765-5 In distribution
E0017710-1 In distribution
E0017765-2 In distribution
71434633 In distribution
E0016590-1 In distribution
71434621 In distribution
E0016786-1 In distribution
71435308 In distribution
71434604 In distribution
71433116 In distribution
71434625 In distribution
E0016877-2 In distribution
E0017710-9 In distribution
71433114 In distribution
E0015465-1 In distribution
E0016590-8 In distribution
71435302 In distribution
71433104 In distribution
71430313 Size 3-4: Size 3-4 In distribution
71434612 In distribution
E0015451-1 In distribution
E0015731-1 In distribution
71433115 In distribution
71433117 In distribution
E0017710-16 In distribution
71433108 In distribution
71434632 In distribution
71935885 In distribution
71435328 In distribution
71433112 In distribution
71434631 In distribution
71435325 In distribution
71435332 In distribution
E0017710-7 In distribution
71435305 In distribution
E0017764-1 In distribution
71434603 In distribution
E0017765-3 In distribution
E0018279-1 In distribution
E0015739-1 In distribution
71430312 Size 3-4: Size 3-4 In distribution
E0017678-1 In distribution
71435313 In distribution
71430054 Size 5-6: Size 5-6 In distribution
E0016590-7 In distribution
71430304 Size 3-4: Size 3-4 In distribution
71433121 In distribution
71430303 Size 3-4: Size 3-4 In distribution
71435306 In distribution
E0016590-5 In distribution
71430044 Size 3-4: Size 3-4 In distribution
E0015771-1 In distribution
71430052 Right: Right In distribution
71434628 In distribution
71434629 In distribution
E0017710-3 In distribution
71434619 In distribution
71435312 In distribution
E0017710-12 In distribution
71430043 Left: Left In distribution
71435315 In distribution
71430055 Right: Right In distribution
71433106 In distribution
71435331 In distribution
E0015929-1 In distribution
E0017475-1 In distribution
71430056 Size 7-8: Size 7-8 In distribution
E0015667-3 In distribution
E0016606-4 In distribution
E0017710-5 In distribution
71430045 Left: Left In distribution
71435311 In distribution
E0017765-4 In distribution
71434609 In distribution
71430309 Right: Right In distribution
E0017710-8 In distribution
71433103 In distribution
71434606 In distribution
71435335 In distribution
E0016652-1 In distribution
71433102 In distribution
71435333 In distribution
71434615 In distribution
71430311 Size 1-2: Size 1-2 In distribution
71433122 In distribution
71435314 In distribution
71434627 In distribution
E0017710-6 In distribution
71435326 In distribution
71935887 In distribution
71435303 In distribution
71433118 In distribution
71433105 In distribution
71430316 Right: Right In distribution
71434623 In distribution
71434634 In distribution
E0017710-10 In distribution
E0015487-1 In distribution
71433111 In distribution
71430057 Right: Right In distribution
71435318 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