Link Embrace Shoulder System Line Extension
Surgical instrument handle, non-torque-limiting - LINK Embrace Shoulder System
2manufacturers in China registered for this device type
32catalogue 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) | K231445 |
| Record published | 2024-01-22 |
| Record revised | 2025-02-06 (version 2) |
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 |
|---|---|---|
| 643-010/01 | In distribution | |
| 646-042/05 | In distribution | |
| 645-074/25 | In distribution | |
| 645-081/25 | In distribution | |
| 645-076/45 | In distribution | |
| 645-081/30 | In distribution | |
| 645-074/60 | In distribution | |
| 645-074/20 | In distribution | |
| 645-081/05 | In distribution | |
| 645-074/35 | In distribution | |
| 645-076/55 | In distribution | |
| 645-076/50 | In distribution | |
| 645-076/60 | In distribution | |
| 645-081/73 | In distribution | |
| 645-076/25 | In distribution | |
| 645-076/30 | In distribution | |
| 645-081/20 | In distribution | |
| 645-074/55 | In distribution | |
| 645-076/35 | In distribution | |
| 645-081/15 | In distribution | |
| 645-076/20 | In distribution | |
| 645-074/50 | In distribution | |
| 645-074/30 | In distribution | |
| 646-042/04 | In distribution | |
| 645-074/40 | In distribution | |
| 645-081/59 | In distribution | |
| 645-074/45 | In distribution | |
| 645-081/10 | In distribution | |
| 645-081/06 | In distribution | |
| 645-076/40 | In distribution | |
| 646-036/05 | In distribution | |
| 645-081/03 | 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 |
| Link Embrace Shoulder System | Waldemar Link GmbH & Co. KG | 64 |
| Anatomical Shoulder™ Domelock® | Zimmer, Inc. | 43 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 38 |
| 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.