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GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD DIAMETER 50mm +3
2manufacturers in China registered for this device type
50catalogue numbers in this listing
1510(k) clearance
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 | Depuy (Ireland), Ireland |
|---|---|
| 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 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2022-02-25 |
| Record revised | 2024-03-26 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1140-20-350 | In distribution | |
| 1140-10-052 | In distribution | |
| 2240-10-042 | In distribution | |
| 2240-10-054 | In distribution | |
| 2240-11-042 | In distribution | |
| 2240-30-150 | In distribution | |
| 2240-11-048 | In distribution | |
| 1140-10-050 | In distribution | |
| 2240-11-052 | In distribution | |
| 2240-10-044 | In distribution | |
| 1140-20-052 | In distribution | |
| 1140-10-054 | In distribution | |
| 1140-10-042 | In distribution | |
| 2240-10-056 | In distribution | |
| 2240-11-056 | In distribution | |
| 1140-20-344 | In distribution | |
| 1140-20-340 | In distribution | |
| 2240-11-054 | In distribution | |
| 1140-10-044 | In distribution | |
| 1140-20-352 | In distribution | |
| 1140-20-346 | In distribution | |
| 2240-10-058 | In distribution | |
| 1140-20-040 | In distribution | |
| 2240-90-100 | In distribution | |
| 2240-10-052 | In distribution | |
| 1140-20-354 | In distribution | |
| 2240-10-050 | In distribution | |
| 2240-90-200 | In distribution | |
| 1140-20-042 | In distribution | |
| 2240-11-050 | In distribution | |
| 1140-20-056 | In distribution | |
| 1140-20-048 | In distribution | |
| 2240-10-048 | In distribution | |
| 1140-20-046 | In distribution | |
| 1140-20-044 | In distribution | |
| 1140-10-056 | In distribution | |
| 2240-11-046 | In distribution | |
| 2240-10-046 | In distribution | |
| 2240-11-040 | In distribution | |
| 1140-20-050 | In distribution | |
| 1140-20-054 | In distribution | |
| 2240-10-060 | In distribution | |
| 2240-11-044 | In distribution | |
| 1140-10-040 | In distribution | |
| 1140-10-046 | In distribution | |
| 1140-20-356 | In distribution | |
| 1140-10-048 | In distribution | |
| 1140-20-342 | In distribution | |
| 1140-20-348 | In distribution | |
| 2240-10-040 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comprehensive® Shoulder System | Biomet Orthopedics | 83 |
| Equinoxe | Exactech, Inc. | 60 |
| SMR Stemless | Limacorporate | 51 |
| 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 |
| Inhance | Depuy (Ireland) | 5 |
Showing 12 of 19. All products under Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212683 | 2022-01-19 |
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.