Millennium

Self Tapping Femoral Head Remover Corkscrew

Registry build 21.09.26
1manufacturer
8catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HWI
Manufacturer City Province Registered as Device types
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23

Record

Regulatory record for Millennium
Listed by Avalign Technologies, Inc., United States
FDA product code HWI
Device type Corkscrew
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2021-11-01
Record revised 2023-07-06 (version 2)

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 Millennium
Catalogue number Size Status
1-119101 In distribution
1-010265NUT In distribution
9-31544 In distribution
1-3690 In distribution
1-31544-11 In distribution
1-010265WL In distribution
1-1191 In distribution
1-010265 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Corkscrew Biomet Microfixation 9
Microfracture Awl Zimmer, Inc. 6
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 3
Aesculap Aesculap AG 2
Bencox Corentec Co., Ltd. 2
Cinch Modular Attachments Biomet Orthopedics 2
DePuy Sythes Symmetry Medical 2
Femoral Head Remover, Corkscrew Total Joint Orthopedics, Inc. 1
Juveno™ Femoral Hip System B-ONE Ortho, Corp. 1
Ambler Surgical Ambler Surgical, LLC 1
Pilling Teleflex Medical LLC 1
Corkscrew Medtronic Sofamor Danek, Inc. 1

Showing 12 of 17. All products under Corkscrew

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