Helmut Zepf
Bone Mill Milling Part Only Helical Toothed, FOR Bone Mill 47.954.00
7manufacturers in China registered for this device type
8catalogue 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.
| 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
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | LYS |
| Device type | Bone Mill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
| Record revised | 2023-12-12 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47.958.00 | In distribution | |
| 47.958.03 | In distribution | |
| 47.958.01 | In distribution | |
| 47.958.04 | In distribution | |
| 47.954.35 | In distribution | |
| 47.955.10 | In distribution | |
| 47.954.01 | In distribution | |
| 47.954.55 | In distribution |
Same 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 |
| 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 |
| OrthoMedFlex | Orthomedflex LLC | 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.