Easytech Anatomical Shoulder System
EASYTECH ANCHOR BASE TA6V Ø42 mm CEMENTLESS Ti/HA
2manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Fx Solutions, France |
|---|---|
| FDA product code | PKC |
| Device type | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K201391 |
| Record published | 2021-02-18 |
| Record revised | 2021-10-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store away from light and sunlight Store away from moisture |
| Sizes | Outer diameter 30 to 42 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 314-0042 | Outer Diameter 42 mm | In distribution |
| 314-0034 | Outer Diameter 34 mm | In distribution |
| 314-0038 | Outer Diameter 38 mm | In distribution |
| 314-0030 | Outer Diameter 30 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comprehensive® Shoulder System | Biomet Orthopedics | 83 |
| Equinoxe | Exactech, Inc. | 60 |
| SMR Stemless | Limacorporate | 51 |
| Global Icon | Depuy (Ireland) | 50 |
| Sidus® Stem-Free Shoulder | Zimmer, Inc. | 39 |
| OsseoFit™ Stemless Shoulder | Zimmer, Inc. | 38 |
| DJO Surgical | Encore Medical, L.P. | 32 |
| Tornier Simpliciti® Shoulder System | Tornier Inc. | 27 |
| Simpliciti™ | Tornier Inc. | 27 |
| Arthrex® | Arthrex, Inc. | 21 |
| Tornier Perform | Tornier Inc. | 10 |
| FX V135 | Fx Solutions | 10 |
Showing 12 of 19. All products under Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
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.