Embrace Shoulder System
13 catalogue numbers from 641-075/14, listed by Waldemar Link GmbH & Co. KG, Germany, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
13catalogue 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) | K212992 |
| Record published | 2023-01-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 641-075/14 | In distribution | |
| 641-265/15 | In distribution | |
| 641-135/16 | In distribution | |
| 641-045/16 | In distribution | |
| 641-205/15 | In distribution | |
| 641-265/14 | In distribution | |
| 641-075/17 | In distribution | |
| 641-040/14 | In distribution | |
| 641-040/18 | In distribution | |
| 641-165/13 | In distribution | |
| 641-135/14 | In distribution | |
| 641-205/16 | In distribution | |
| 641-075/19 | 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 |
| 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 |
| 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.