Bone Mill

Large Shielded Calcar Planer

Registry build 21.09.26
7manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (2), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LYS
Manufacturer City Province Registered as Device types
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Zhejiang Longyou Landmedical Technology Co., Ltd. Longyou Zhejiang Contract manufacturer 7
Shenzhen HYS Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Changzhou Xietong Industries Co., Ltd. Changzhou Jiangsu Exporter 11
Changzhou Centrau Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 9

Record

Regulatory record for Bone Mill
Listed by Depuy (Ireland), Ireland
FDA product code LYS
Device type Bone Mill
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-02-01
Record revised 2023-10-04 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Bone Mill
Catalogue number Size Status
4861-00-100 In distribution
4861-00-020 In distribution
L94010 In distribution
4861-00-010 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vanguard XP® Instrumentation Biomet Orthopedics 16
Vanguard XP Biomet Orthopedics 16
Bone Mill Hager & Meisinger Gesellschaft mit beschränkter Haftung 9
Bone Mill Depuy Intl., Ltd. 8
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 8
Bone Mill KLS-Martin L.P. 8
Innomed, Inc. Innomed, Inc. 8
Renovo Life Renovo Life, LLC 7
Custom Medicrea International 5
ACE Ace Surgical Supply Co., Inc. 5
Ergoplant Aesculap AG 5
Diplomat Signus Medizintechnik Gmbh 5

Showing 12 of 84. All products under Bone Mill

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