Endoskeleton® TA

Trial, 12 Deg Lordotic, Standard, 17mm

Registry build 21.09.26
21manufacturers in China registered for this device type
60catalogue 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 Endoskeleton® TA
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Premarket notification Exempt
Record published 2016-12-15
Record revised 2021-04-01 (version 7)

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
Sizes Depth 21 to 27 mm; angle 7 to 12 °; width 32 to 40 mm; height 8 to 17 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Endoskeleton® TA
Catalogue number Size Status
2112-9117 Depth 21 mm In distribution
2112-9311 Depth 27 mm In distribution
2112-9115 width(MLxAP), 32 x 21, mm In distribution
2106-9310 width(MLxAP), 40 x 27, mm In distribution
2106-9314 Depth 27 mm In distribution
2112-9314 width(MLxAP), 40 x 27, mm In distribution
2112-9109 Depth 21 mm In distribution
2112-9208 width(MLxAP), 36 x 24, mm In distribution
2112-9310 Width 40 mm In distribution
2106-9117 width(MLxAP), 32 x 21, mm In distribution
2112-9312 width(MLxAP), 40 x 27, mm In distribution
2112-9315 width(MLxAP), 40 x 27, mm In distribution
2106-9313 width(MLxAP), 40 x 27, mm In distribution
2106-9216 Depth 24 mm In distribution
2106-9315 width(MLxAP), 40 x 27, mm In distribution
2106-9115 Depth 21 mm In distribution
2106-9116 Depth 21 mm In distribution
2112-9112 width(MLxAP), 32 x 21, mm In distribution
2112-9316 width(MLxAP), 40 x 27, mm In distribution
2106-9308 width(MLxAP), 40 x 27, mm In distribution
2112-9110 Width 32 mm In distribution
2106-9215 width(MLxAP), 36 x 24, mm In distribution
2112-9114 Depth 21 mm In distribution
2112-9210 width(MLxAP), 36 x 24, mm In distribution
2112-9317 Width 40 mm In distribution
2106-9209 width(MLxAP), 36 x 24, mm In distribution
2106-9309 Depth 27 mm In distribution
2106-9213 Width 36 mm In distribution
2112-9209 Width 36 mm In distribution
2112-9217 Angle 12 ° In distribution
2106-9317 width(MLxAP), 40 x 27, mm In distribution
2106-9316 Width 40 mm In distribution
2112-9216 Angle 12 ° In distribution
2112-9313 Angle 12 ° In distribution
2112-9116 Angle 12 ° In distribution
2106-9208 Angle 7 ° In distribution
2112-9212 Angle 12 ° In distribution
2106-9110 Width 32 mm In distribution
2112-9215 Angle 12 ° In distribution
2112-9211 width(MLxAP), 36 x 24, mm In distribution
2112-9213 width(MLxAP), 36 x 24, mm In distribution
2112-9308 Lordotic Angle 12 Deg In distribution
2112-9108 width(MLxAP), 32 x 21, mm In distribution
2112-9309 Width 40 mm In distribution
2106-9210 Width 36 mm In distribution
2106-9114 Width 32 mm In distribution
2106-9312 width(MLxAP), 40 x 27, mm In distribution
2106-9109 width(MLxAP), 32 x 21, mm In distribution
2106-9112 Width 32 mm In distribution
2106-9311 Depth 27 mm In distribution
2106-9214 Angle 7 ° In distribution
2112-9113 width(MLxAP), 32 x 21, mm In distribution
2106-9113 width(MLxAP), 32 x 21, mm In distribution
2106-9217 width(MLxAP), 36 x 24, mm In distribution
2106-9212 Width 36 mm In distribution
2106-9108 Depth 21 mm In distribution
2106-9211 Width 36 mm In distribution
2106-9111 Height 11 mm In distribution
2112-9214 Depth 24 mm In distribution
2112-9111 Angle 12 ° 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