Equinoxe
Stemless Humeral Component Drill, Size 2
2manufacturers in China registered for this device type
60catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Exactech, Inc., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K173388 |
| Record published | 2022-08-18 |
| Record revised | 2025-03-06 (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, serial number |
| Sizes | Outer diameter 3.2 to 53 mm; length 178 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 319-01-01 | SIZE 1 | In distribution |
| 300-60-02 | Size 2 | In distribution |
| 319-00-10 | In distribution | |
| SPI-039531 | In distribution | |
| 300-63-02 | Size 2 | In distribution |
| 319-00-14 | SMALL | In distribution |
| 319-01-32 | Length 178 mm | In distribution |
| 310-62-41 | 41mm x 13mm x ALPHA | In distribution |
| 310-61-44 | Short | In distribution |
| 319-00-02 | SIZE 2 | In distribution |
| 300-62-01 | Cage | In distribution |
| SPI-045502 | In distribution | |
| 310-61-38 | Short | In distribution |
| 319-00-44 | Outer Diameter 44 mm | In distribution |
| 319-00-47 | Outer Diameter 47 mm | In distribution |
| 319-12-38 | 38mm x 13mm x ALPHA | In distribution |
| 319-01-03 | SIZE 3 | In distribution |
| 319-00-01 | SIZE 1 | In distribution |
| 319-12-47 | 47mm x 15mm x BETA | In distribution |
| 300-60-03 | Size 3 | In distribution |
| 319-00-11 | In distribution | |
| 319-12-41 | 41mm x 13mm x ALPHA | In distribution |
| SPI-045501 | In distribution | |
| 319-00-03 | SIZE 3 | In distribution |
| 319-09-56 | 56mm | In distribution |
| SPI-045258 | In distribution | |
| 319-01-02 | SIZE 2 | In distribution |
| 319-00-30 | In distribution | |
| 319-00-53 | Outer Diameter 53 mm | In distribution |
| 310-61-53 | 53mm | In distribution |
| 310-61-41 | 41mm | In distribution |
| 319-12-44 | 44mm x 14mm x BETA | In distribution |
| 319-09-50 | 50mm | In distribution |
| 310-60-47 | 47mm | In distribution |
| 319-09-44 | 44mm | In distribution |
| 319-00-50 | Outer Diameter 50 mm | In distribution |
| 319-01-00 | In distribution | |
| 319-00-16 | LARGE | In distribution |
| 310-62-50 | 50mm x 16mm x BETA | In distribution |
| 319-00-15 | MEDIUM | In distribution |
| 300-63-03 | Size 3 | In distribution |
| 319-12-36 | 36mm x 13mm x ALPHA | In distribution |
| 319-00-41 | Outer Diameter 41 mm | In distribution |
| 310-62-36 | 36mm x 13mm x ALPHA | In distribution |
| 310-61-50 | Short | In distribution |
| 310-62-47 | 47mm x 15mm x BETA | In distribution |
| 310-62-44 | 44mm x 14mm x BETA | In distribution |
| 310-60-53 | 53mm | In distribution |
| 310-60-50 | Extra Short | In distribution |
| 300-62-02 | Size 2 | In distribution |
| 310-60-41 | 41mm | In distribution |
| 310-61-47 | 47mm | In distribution |
| 300-60-01 | Size 1 | In distribution |
| 310-62-38 | 38mm x 13mm x ALPHA | In distribution |
| 319-00-38 | Outer Diameter 38 mm | In distribution |
| 310-60-38 | Extra Short | In distribution |
| 319-12-50 | 50mm x 16mm x BETA | In distribution |
| 300-62-03 | Cage | In distribution |
| 300-63-01 | Size 1 | In distribution |
| 310-60-44 | Extra Short | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comprehensive® Shoulder System | Biomet Orthopedics | 83 |
| 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 |
| 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 |
|---|---|
| K192097 | 2020-04-29 |
| K173388 | 2018-03-09 |
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.