Made-To-Order

Cortiloc Cannulated Central Drill

Registry build 21.09.26
23manufacturers in China registered for this device type
131catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (6), Guangdong (3). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWE
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Autocam Medical Devices (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Shaanxi Ansen Medical Technology Development Co., Ltd. Xi’An Shaanxi Contract manufacturer 7
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Record

Regulatory record for Made-To-Order
Listed by Tornier Inc., United States
FDA product code HWE
Device type Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class Class 1
Regulation 21 CFR 878.4820
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-11-29
Record revised 2023-10-04 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number
Distribution end date 2022-11-30

Catalogue Numbers

Catalogue numbers for Made-To-Order
Catalogue number Size Status
9028353 Size: L40 In distribution
9027356 Size: L60 In distribution
9027892 Size: 51 In distribution
9028354 Size: L50 In distribution
9028374 Size: L50 In distribution
9027193 Size: M35 In distribution
9027348 Size: S30 In distribution
9027359 Size: XL60 In distribution
9027712 In distribution
9028352 Size: M40 In distribution
9027466 Size: LO In distribution
9028051 In distribution
9027467 Size: HI In distribution
9027194 Size: M40 In distribution
9028371 Size: M35 In distribution
9027375 Size: S40 In distribution
9028029 Size: 25 – 36mm In distribution
9028355 Size: L60 In distribution
9028889 In distribution
9027191 Size: S40 In distribution
9027216 Size: Long In distribution
9027351 Size: M30 In distribution
9027918 Size: 53mm In distribution
9028369 Size: S40 In distribution
9028368 Size: S35 In distribution
9027353 Size: M40 In distribution
9027996 Size: 25 – 42mm In distribution
9027403 Size: Small – Medium In distribution
9027189 Size: S30 In distribution
9027567 Size: L40 In distribution
9028350 Size: M30 In distribution
9027195 Size: L40 In distribution
9027928 Large – XL In distribution
9028343 Size: 58mm In distribution
9028341 Size: 51mm In distribution
9027197 Size: L60 In distribution
9027469 Size: Small In distribution
9027895 Size: 58 In distribution
9028496 In distribution
9027354 Size: L40 In distribution
9027929 Small – Medium In distribution
9027350 Size: S40 In distribution
9027464 In distribution
9027896 Size: 62 In distribution
9027484 Size: 5 – 6 In distribution
9028032 Size: 29 – 42mm In distribution
9027472 Size: Extra Large In distribution
9027900 Size: 5.4mm In distribution
9027526 Size: 25mm In distribution
9028338 Size: 44mm In distribution
9027358 Size: XL50 In distribution
9028377 Size: XL50 In distribution
9028027 Size: 25mm In distribution
9027357 Size: XL40 In distribution
9027564 Size: M30 In distribution
9027998 Size: 29 – 42mm In distribution
9027192 Size: M30 In distribution
9028030 Size: 25 – 42mm In distribution
9027404 Size: Large – XL In distribution
9028347 Size: S30 In distribution
9028340 Size: 48mm In distribution
9028339 Size: 46mm In distribution
9028356 Size: XL40 In distribution
9027926 Size: 15.75mm In distribution
9027862 Size: 25 – 42mm In distribution
9027874 Size: 5.1mm In distribution
9028456 Size: 29mm In distribution
9028375 Size: L60 In distribution
9027349 Size: S35 In distribution
9028373 Size: L40 In distribution
9028031 Size: 29 – 36mm In distribution
9028367 Size: S30 In distribution
9028175 Size: 5.35mm In distribution
9027889 Size: 44 In distribution
9028370 Size: M30 In distribution
9027570 Size: XL40 In distribution
9028378 Size: XL60 In distribution
9027483 Size: 3 – 4 In distribution
9028348 Size: S35 In distribution
9027377 Size: M35 In distribution
9028000 Size: 29mm In distribution
9027198 Size: XL40 In distribution
9028351 Size: M35 In distribution
9027748 Size: 6.5mm In distribution
9027190 Size: S35 In distribution
9027999 Size: 25mm In distribution
9027465 In distribution
9027470 Size: Medium In distribution
9027463 In distribution
9028342 Size: 55mm In distribution
9027199 Size: XL50 In distribution
9027891 Size: 48 In distribution
9028408 Size: 36mm In distribution
9027200 Size: XL60 In distribution
9027997 Size: 29 – 36mm In distribution
9027355 Size: L50 In distribution
9027824 Small – Medium In distribution
9027716 Size: 4mm In distribution
9027832 Size: 6.5mm In distribution
9027459 In distribution
9028101 In distribution
9027379 Size: L40 In distribution
9027215 Size: Short In distribution
9027927 Size: 6mm In distribution
9028358 Size: XL60 In distribution
9027893 Size: 53 In distribution
9027995 Size: 25 – 36mm In distribution
9028372 Size: M40 In distribution
9028344 Size: 62mm In distribution
9028357 Size: XL50 In distribution
9027711 In distribution
9027196 Size: L50 In distribution
9027894 Size: 55 In distribution
9027468 In distribution
9028807 Size: Short In distribution
9027561 Size: S30 In distribution
9027471 Size: Large In distribution
9027930 Large – XL In distribution
9027352 Size: M35 In distribution
9027890 Size: 46 In distribution
9027825 Large – XL In distribution
9028349 Size: S40 In distribution
9028808 Size: Long In distribution
9028028 Size: 29mm In distribution
9028376 Size: XL40 In distribution
9028049 In distribution
9028804 Size: 48mm Withdrawn
9028803 Size: 44mm Withdrawn
9028802 Size: 40mm Withdrawn
9028805 Size: 52mm Withdrawn
9028806 Size: 56mm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
EZX Imedicom Co., Ltd. 441
Arthrex® Arthrex, Inc. 391
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Stryker GmbH 284
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 231
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Synthes Gmbh 226
Brasseler EZX Imedicom Co., Ltd. 187
Conserve® Microport Orthopedics Inc. 158
R3 Smith & Nephew, Inc. 147
Trigen Smith & Nephew, Inc. 139
MicroPort Microport Orthopedics Inc. 134
Profemur® Microport Orthopedics Inc. 129
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Exactech, Inc. 129

Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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