Z1™ Hip System
3 catalogue numbers from 611777553, listed by Zimmer, Inc., United States, under Bone Mill. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
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 | Zimmer, Inc., United States |
|---|---|
| FDA product code | LYS |
| Device type | Bone Mill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-09-09 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 611777553 | 42 mm | In distribution |
| 611777554 | 46 mm | In distribution |
| 611777552 | 38 mm | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K860356 | 1986-07-08 |
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.