Endoskeleton® TAS

Anterolateral, 12 Deg Lordotic, Rasp, Standard, 13mm

Registry build 21.09.26
12manufacturers in China registered for this device type
93catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (4), Guangdong (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTR
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
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Shenzhen Xiazhifeng Electronic Co., Ltd. Shenzhen Guangdong Contract manufacturer 25

Record

Regulatory record for Endoskeleton® TAS
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code HTR
Device type Rasp
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2019-09-11
Record revised 2022-06-10 (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 Height 10 to 20 mm; angle 7 to 24 °; width 32 to 40 mm; depth 21 to 27 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Endoskeleton® TAS
Catalogue number Size Status
2312-7312 width(MLxAP), 40 x 27, mm In distribution
2312-7113 Angle 12 ° In distribution
2324-7114 Angle 24 ° In distribution
2324-7216 Depth 24 mm In distribution
2324-7218 Angle 24 ° In distribution
2320-7320 width(MLxAP), 40 x 27, mm In distribution
2307-7312 Angle 7 ° In distribution
2324-7320 width(MLxAP), 40 x 27, mm In distribution
2307-7116 width(MLxAP), 32 x 21, mm In distribution
2320-7312 Angle 20 ° In distribution
2316-7320 Depth 27 mm In distribution
2324-7120 Depth 21 mm In distribution
2320-7114 width(MLxAP), 32 x 21, mm In distribution
2320-7220 width(MLxAP), 36 x 24, mm In distribution
2312-7114 Angle 12 ° In distribution
2312-7310 width(MLxAP), 40 x 27, mm In distribution
2307-7112 Height 12 mm In distribution
2320-7212 Angle 20 ° In distribution
2312-7111 Angle 12 ° In distribution
2307-7216 width(MLxAP), 36 x 24, mm In distribution
2316-7120 width(MLxAP), 32 x 21, mm In distribution
2312-7115 Width 32 mm In distribution
2316-7212 Angle 16 ° In distribution
2307-7317 Angle 7 ° In distribution
2312-7314 Angle 12 ° In distribution
2324-7316 width(MLxAP), 40 x 27, mm In distribution
2312-7315 Width 40 mm In distribution
2312-7216 Height 16 mm In distribution
2320-7316 width(MLxAP), 40 x 27, mm In distribution
2316-7110 width(MLxAP), 32 x 21, mm In distribution
2307-7111 Depth 21 mm In distribution
2324-7318 Width 40 mm In distribution
2307-7214 Lordotic Angle 7 Deg In distribution
2316-7118 Depth 21 mm In distribution
2307-7313 Angle 7 ° In distribution
2307-7217 Height 17 mm In distribution
2316-7210 Depth 24 mm In distribution
2316-7316 width(MLxAP), 40 x 27, mm In distribution
2312-7117 width(MLxAP), 32 x 21, mm In distribution
2316-7214 Depth 24 mm In distribution
2316-7220 Depth 24 mm In distribution
2312-7215 Width 36 mm In distribution
2320-7116 Depth 21 mm In distribution
2320-7314 width(MLxAP), 40 x 27, mm In distribution
2312-7110 Height 10 mm In distribution
2307-7117 Angle 7 ° In distribution
2307-7215 Height 15 mm In distribution
2316-7318 Angle 16 ° In distribution
2316-7114 Depth 21 mm In distribution
2307-7310 width(MLxAP), 40 x 27, mm In distribution
2316-7310 Angle 16 ° In distribution
2307-7211 Width 36 mm In distribution
2307-7115 Width 32 mm In distribution
2320-7112 Depth 21 mm In distribution
2320-7120 width(MLxAP), 32 x 21, mm In distribution
2312-7214 width(MLxAP), 36 x 24, mm In distribution
2307-7110 Depth 21 mm In distribution
2312-7212 Angle 12 ° In distribution
2307-7210 Height 10 mm In distribution
2307-7113 Width 32 mm In distribution
2316-7312 Angle 16 ° In distribution
2324-7116 Width 32 mm In distribution
2324-7314 width(MLxAP), 40 x 27, mm In distribution
2320-7216 Depth 24 mm In distribution
2312-7317 Width 40 mm In distribution
2307-7212 Angle 7 ° In distribution
2307-7114 Angle 7 ° In distribution
2316-7218 Angle 16 ° In distribution
2307-7315 Height 15 mm In distribution
2312-7116 Depth 21 mm In distribution
2307-7314 width(MLxAP), 40 x 27, mm In distribution
2316-7216 Width 36 mm In distribution
2307-7311 Depth 27 mm In distribution
2324-7220 Angle 24 ° In distribution
2316-7112 Depth 21 mm In distribution
2312-7210 width(MLxAP), 36 x 24, mm In distribution
2312-7211 width(MLxAP), 36 x 24, mm In distribution
2316-7116 Angle 16 ° In distribution
2312-7213 Angle 12 ° In distribution
2316-7314 Depth 27 mm In distribution
2320-7218 Depth 24 mm In distribution
2312-7313 Depth 27 mm In distribution
2320-7318 Width 40 mm In distribution
2312-7311 Depth 27 mm In distribution
2312-7316 Depth 27 mm In distribution
2312-7217 width(MLxAP), 36 x 24, mm In distribution
2312-7112 Depth 21 mm In distribution
2307-7316 width(MLxAP), 40 x 27, mm In distribution
2324-7118 width(MLxAP), 32 x 21, mm In distribution
2324-7214 Width 36 mm In distribution
2307-7213 Width 36 mm In distribution
2320-7118 width(MLxAP), 32 x 21, mm In distribution
2320-7214 Angle 20 ° In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 240
TiWAVE C Cervical Cage System Kalitec Direct, LLC 232
Tranquil-C™ Nexus Spine, L.L.C. 158
Calix Spinal Implant System Xtant Medical Holdings, Inc. 143
Rasp Medtronic Sofamor Danek, Inc. 109
Specials Seaspine Orthopedics Corporation 109
Stryker Avalign Technologies, Inc. 105
Intervertebral Disc Preparation Instruments Alphatec Spine, Inc. 90
Cambria Seaspine Orthopedics Corporation 85
IdentiTi Alphatec Spine, Inc. 83
Link Instruments – Rasps, compressors and broaches Waldemar Link GmbH & Co. KG 83
Rasp Zimmer, Inc. 77

Showing 12 of 378. All products under Rasp

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