Link Embrace Shoulder System
Bone Screws, and Central Cancellous Bone Screw, Ca
8manufacturers in China registered for this device type
54catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K200368 |
| Record published | 2021-03-24 |
| Record revised | 2025-02-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 645-070/30 | In distribution | |
| 640-110/13 | In distribution | |
| 643-036/26 | In distribution | |
| 640-110/19 | In distribution | |
| 642-010/00 | In distribution | |
| 640-110/17 | In distribution | |
| 645-077/25 | In distribution | |
| 642-010/06 | In distribution | |
| 642-053/21 | In distribution | |
| 645-080/30 | In distribution | |
| 645-075/25 | In distribution | |
| 640-175/20 | In distribution | |
| 641-120/12 | In distribution | |
| 643-242/03 | In distribution | |
| 640-110/15 | In distribution | |
| 640-100/16 | In distribution | |
| 643-039/13 | In distribution | |
| 643-042/03 | In distribution | |
| 645-080/56 | In distribution | |
| 643-242/10 | In distribution | |
| 643-036/23 | In distribution | |
| 640-110/22 | In distribution | |
| 645-073/20 | In distribution | |
| 646-036/03 | In distribution | |
| 646-042/00 | In distribution | |
| 643-236/10 | In distribution | |
| 643-039/20 | In distribution | |
| 642-041/15 | In distribution | |
| 645-073/50 | In distribution | |
| 641-120/14 | In distribution | |
| 645-070/40 | In distribution | |
| 643-039/10 | In distribution | |
| 640-100/12 | In distribution | |
| 643-239/13 | In distribution | |
| 640-175/15 | In distribution | |
| 645-001/52 | In distribution | |
| 646-039/00 | In distribution | |
| 643-236/26 | In distribution | |
| 642-010/01 | In distribution | |
| 643-042/16 | In distribution | |
| 646-036/00 | In distribution | |
| 645-070/60 | In distribution | |
| 645-070/25 | In distribution | |
| 640-100/13 | In distribution | |
| 643-236/20 | In distribution | |
| 642-010/02 | In distribution | |
| 643-042/10 | In distribution | |
| 643-039/26 | In distribution | |
| 642-044/14 | In distribution | |
| 643-036/00 | In distribution | |
| 645-075/20 | In distribution | |
| 643-239/16 | In distribution | |
| 643-039/00 | In distribution | |
| 643-042/20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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.