Signature ONE Software Package
v. 1.0
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Orthosoft, Inc., Canada |
|---|---|
| FDA product code | QHE |
| Device type | Shoulder Arthroplasty Implantation System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K190595 |
| Record published | 2022-07-05 |
| Record revised | 2023-12-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 302.4018 | In distribution | |
| 302.4018 | In distribution | |
| 302.4018 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Space Shoulder | Limacorporate | 13 |
| Core Shoulder System | Link BIO Corp | 13 |
| Blueprint | Tornier Inc. | 5 |
| SurgiCase Planner | Materialise NV | 3 |
| Arthrex® | Arthrex, Inc. | 3 |
| Signature ONE | Orthosoft, Inc. | 2 |
| Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left | Orthosoft, Inc. | 2 |
| AtlasPlan | Materialise NV | 2 |
| Match Point System | Materialise NV | 2 |
| Comprehensive® Total Shoulder Guide and Bone Model Right | Orthosoft, Inc. | 2 |
| Comprehensive® Reverse Shoulder Mini Guide and Bone Model Left | Orthosoft, Inc. | 2 |
| Shoulder Pure Planning | Orthosoft, Inc. | 1 |
Showing 12 of 16. All products under Shoulder Arthroplasty Implantation System
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.