InTess C Cervical Cage System

Cervical Rasp, 14 x 11, 10mm, 0 Degree, No Taper

Registry build 21.09.26
12manufacturers in China registered for this device type
48catalogue 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 InTess C Cervical Cage System
Listed by Kalitec Direct, LLC, United States
FDA product code HTR
Device type Rasp
Device class Class 1
Regulation 21 CFR 878.4800
Record published 2018-09-13
Record revised 2022-06-10 (version 3)

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 InTess C Cervical Cage System
Catalogue number Size Status
09-K01-308T In distribution
09-K01-409T In distribution
09-K01-807T In distribution
09-K01-807N In distribution
09-K01-710T In distribution
09-K01-405T In distribution
09-K01-805T In distribution
09-K01-810T In distribution
09-K01310T In distribution
09-K01-307N In distribution
09-K01-709N In distribution
09-K01-806T In distribution
09-K01-305T In distribution
09-K01-310N In distribution
09-K01-808T In distribution
09-K01-405N In distribution
09-K01-705N In distribution
09-K01-306T In distribution
09-K01-707T In distribution
09-K01-410N In distribution
09-K01-406T In distribution
09-K01-407T In distribution
09-K01-710N In distribution
09-K01-705T In distribution
09-K01-409N In distribution
09-K01-707N In distribution
09-K01-709T In distribution
09-K01-306N In distribution
09-K01-408N In distribution
09-K01-806N In distribution
09-K01-706N In distribution
09-K01-406N In distribution
09-K01-810N In distribution
09-K01-308N In distribution
09-K01-309T In distribution
09-K01-805N In distribution
09-K01-809T In distribution
09-K01-808N In distribution
09-K01-309N In distribution
09-K01-410T In distribution
09-K01-408T In distribution
09-K01-708T In distribution
09-K01-307T In distribution
09-K01-809N In distribution
09-K01-708N In distribution
09-K01-305N In distribution
09-K01-706T In distribution
09-K01-407N 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
Endoskeleton® TAS Medtronic Sofamor Danek, Inc. 93
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

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