SMR Stemless
SMR STEMLESS Shoulder - Counter Torque for Humeral Head Adaptors
2manufacturers in China registered for this device type
51catalogue 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 | Limacorporate, Italy |
|---|---|
| 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 |
| Record published | 2023-05-26 |
| Record revised | 2024-09-11 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9013.55.028 | Large | In distribution |
| 1355.14.240 | # X-LARGE | In distribution |
| 9013.55.431 | #X-Small | In distribution |
| 9013.55.079 | #X-LARGE | In distribution |
| 1335.15.204 | 4MM ECCENTRICAL | In distribution |
| 9013.55.045 | Medium Short | In distribution |
| 1355.14.233 | # SMALL | In distribution |
| 9013.55.058 | Large | In distribution |
| 9013.55.049 | X-LARGE SHORT | In distribution |
| 9013.55.435 | Medium | In distribution |
| 9013.55.030 | In distribution | |
| 9013.55.085 | Medium Short | In distribution |
| 9013.55.099 | #X-Large | In distribution |
| 1355.14.135 | # MEDIUM SHORT | In distribution |
| 9013.55.055 | Medium | In distribution |
| 9013.55.051 | X-SMALL | In distribution |
| 9013.35.200 | In distribution | |
| 1355.14.138 | # LARGE SHORT | In distribution |
| 9013.55.089 | #X-Large Short | In distribution |
| 1355.14.140 | # X-LARGE SHORT | In distribution |
| 1335.15.202 | 2MM ECCENTRICAL | In distribution |
| 9013.55.098 | Large | In distribution |
| 9013.55.029 | X-LARGE | In distribution |
| 9013.55.439 | #X-Large | In distribution |
| 9013.55.071 | X-SMALL | In distribution |
| 9013.55.059 | X-LARGE | In distribution |
| 9013.55.088 | Large Short | In distribution |
| 1355.14.133 | # SMALL SHORT | In distribution |
| 9013.55.048 | Large Short | In distribution |
| 9013.55.021 | X-SMALL | In distribution |
| 9013.55.091 | #X-Small | In distribution |
| 9013.55.023 | Small | In distribution |
| 9013.55.025 | Medium | In distribution |
| 9013.55.078 | #LARGE | In distribution |
| 9013.55.433 | Small | In distribution |
| 1335.15.200 | NEUTRAL | In distribution |
| 9013.55.095 | Medium | In distribution |
| 9013.55.093 | Small | In distribution |
| 9013.55.075 | #MEDIUM | In distribution |
| 9013.55.081 | #X-Small Short | In distribution |
| 9013.55.083 | Small Short | In distribution |
| 1355.14.231 | # X-SMALL | In distribution |
| 1355.14.238 | # LARGE | In distribution |
| 9013.55.438 | Large | In distribution |
| 9013.55.073 | SMALL | In distribution |
| 9013.55.041 | X-SMALL SHORT | In distribution |
| 9013.55.043 | Small Short | In distribution |
| 9013.55.053 | Small | In distribution |
| 1355.14.235 | # MEDIUM | In distribution |
| 9013.55.015 | In distribution | |
| 1355.14.131 | # X-SMALL SHORT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comprehensive® Shoulder System | Biomet Orthopedics | 83 |
| Equinoxe | Exactech, Inc. | 60 |
| 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 |
| 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
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.