A.l.p.s. Mvx™

2.0MM Calibrated Drill BIT

Registry build 21.09.26
27manufacturers in China registered for this device type
40catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (12), Shanghai (5), Guangdong (4). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTW
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
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
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
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Autocam Medical Devices (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Aplus (Guangzhou) Medical Technology Company Guangzhou Guangdong Contract manufacturer 6
Changzhou Wastonortho Medical Appliance Co., Ltd. Changzhou Jiangsu Contract manufacturer 5

Showing 12 of 27. All 27 manufacturers in China registered for Bit, Drill

Record

Regulatory record for A.l.p.s. mvX™
Listed by Tyber Medical, United States
FDA product code HTW
Device type Bit, Drill
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2026-06-04
Record revised 2025-08-15 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for A.l.p.s. mvX™
Catalogue number Size Status
770002100A In distribution
770002182A In distribution
770002180 In distribution
770002251 In distribution
770002090A In distribution
770900004A In distribution
770900005A In distribution
770003200 In distribution
770003270 In distribution
770900006A In distribution
770003350A In distribution
770002181A In distribution
770002181 In distribution
770003270A In distribution
770002200A In distribution
770900020 In distribution
770002250 In distribution
770002180A In distribution
770002090 In distribution
770003400 In distribution
770900006 In distribution
770003350 In distribution
770002151 In distribution
770002200 In distribution
770003240A In distribution
770002150A In distribution
770002151A In distribution
770900025 In distribution
770002150 In distribution
770003200A In distribution
770003400A In distribution
770002201 In distribution
770002201A In distribution
770002250A In distribution
770002182 In distribution
770900004 In distribution
770900005 In distribution
770002251A In distribution
770002100 In distribution
770003240 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bit, Drill Sterilmed, Inc. 633
Bit, Drill Synthes Gmbh 412
Arthrex® Arthrex, Inc. 406
Level ONE KLS-Martin L.P. 246
Acumed Acumed LLC 205
Stryker Provision 198
Arthrex Provision 186
Tecomet Tecomet, Inc. 166
Synthes Provision 164
Drill bit Jeil Medical Corporation 134
Bit, Drill AAP Implantate AG 114
Emerge Medical & Design Emerge Technologies, Inc. 110

Showing 12 of 1,958. All products under Bit, Drill

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