Link Embrace Shoulder System
Bone Screws, and Central Cancellous Bone Screw, Co
2manufacturers in China registered for this device type
64catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | PAO |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 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 |
|---|---|---|
| 643-010/03 | In distribution | |
| 640-100/21 | In distribution | |
| 640-110/14 | In distribution | |
| 641-120/22 | In distribution | |
| 642-050/18 | In distribution | |
| 645-090/09 | In distribution | |
| 641-120/24 | In distribution | |
| 645-075/60 | In distribution | |
| 645-075/35 | In distribution | |
| 643-236/00 | In distribution | |
| 643-020/10 | In distribution | |
| 643-036/13 | In distribution | |
| 640-110/24 | In distribution | |
| 640-100/22 | In distribution | |
| 642-038/12 | In distribution | |
| 642-010/04 | In distribution | |
| 643-242/26 | In distribution | |
| 645-021/52 | In distribution | |
| 643-236/16 | In distribution | |
| 642-050/20 | In distribution | |
| 640-175/14 | In distribution | |
| 645-022/58 | In distribution | |
| 643-242/06 | In distribution | |
| 645-075/40 | In distribution | |
| 645-090/13 | In distribution | |
| 640-175/16 | In distribution | |
| 643-236/13 | In distribution | |
| 640-175/12 | In distribution | |
| 641-120/19 | In distribution | |
| 640-100/17 | In distribution | |
| 643-039/16 | In distribution | |
| 645-075/50 | In distribution | |
| 640-175/13 | In distribution | |
| 640-100/14 | In distribution | |
| 640-110/18 | In distribution | |
| 643-236/06 | In distribution | |
| 645-070/20 | In distribution | |
| 645-073/40 | In distribution | |
| 630-001/01 | In distribution | |
| 646-039/03 | In distribution | |
| 643-039/06 | In distribution | |
| 646-530/00 | In distribution | |
| 643-242/16 | In distribution | |
| 640-100/24 | In distribution | |
| 645-075/30 | In distribution | |
| 643-242/00 | In distribution | |
| 640-100/20 | In distribution | |
| 640-175/19 | In distribution | |
| 640-110/20 | In distribution | |
| 645-023/64 | In distribution | |
| 641-120/21 | In distribution | |
| 640-175/18 | In distribution | |
| 640-110/12 | In distribution | |
| 643-042/23 | In distribution | |
| 643-010/00 | In distribution | |
| 643-042/00 | In distribution | |
| 640-175/17 | In distribution | |
| 643-239/00 | In distribution | |
| 643-236/23 | In distribution | |
| 640-100/15 | In distribution | |
| 643-239/23 | In distribution | |
| 640-110/21 | In distribution | |
| 643-039/03 | In distribution | |
| 642-047/17 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 85 |
| Perform™ Humeral System | Tornier Inc. | 76 |
| Comprehensive® Reverse Shoulder | Biomet Orthopedics | 68 |
| Anatomical Shoulder™ Domelock® | Zimmer, Inc. | 43 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 38 |
| Link Embrace Shoulder System Line Extension | Waldemar Link GmbH & Co. KG | 32 |
| Inhance | Depuy (Ireland) | 31 |
| Tornier Perform Humeral System | Tornier Inc. | 17 |
| Comprehensive Instrumentation | Biomet Orthopedics | 16 |
| Embrace Shoulder System | Waldemar Link GmbH & Co. KG | 13 |
| Maestro™ Total Wrist | Biomet Orthopedics | 13 |
| Comprehensive® | Zimmer, Inc. | 11 |
Showing 12 of 29. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
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.