Arthrex®
ECLIPSE TRUNION 49MM, SLOTTED, TPS CaP4.
1manufacturer
58catalogue numbers in this listing
1510(k) clearance
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 | Arthrex, Inc., United States |
|---|---|
| FDA product code | QHQ |
| Device type | Total Shoulder Arthroplasty System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2021-05-26 |
| Record revised | 2026-07-09 (version 8) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-9301-39CPC | In distribution | |
| AR-9449-20 | In distribution | |
| AR-9443-18 | In distribution | |
| AR-9341-18 | In distribution | |
| AR-9351-19 | In distribution | |
| AR-9451-21 | In distribution | |
| AR-9447-20 | In distribution | |
| AR-9441-18 | In distribution | |
| AR-9347-18 | In distribution | |
| AR-9441-16 | In distribution | |
| AR-9345-19 | In distribution | |
| AR-9347-20 | In distribution | |
| AR-9351-21 | In distribution | |
| AR-9451-19 | In distribution | |
| AR-9301-03 | In distribution | |
| AR-9300-47CPC | In distribution | |
| AR-9349-20 | In distribution | |
| AR-9345-17 | In distribution | |
| AR-9455-21 | In distribution | |
| AR-9301-04 | In distribution | |
| AR-9300-49CPC | In distribution | |
| AR-9447-18 | In distribution | |
| AR-9301-41CPC | In distribution | |
| AR-9301-45CPC | In distribution | |
| AR-9301-53CPC | In distribution | |
| AR-9341-16 | In distribution | |
| AR-9300-39CPC | In distribution | |
| AR-9353-20 | In distribution | |
| AR-9455-23 | In distribution | |
| AR-9437-16 | In distribution | |
| AR-9339-16 | In distribution | |
| AR-9449-18 | In distribution | |
| AR-9301-55CPC | In distribution | |
| AR-9300-51CPC | In distribution | |
| AR-9453-22 | In distribution | |
| AR-9453-20 | In distribution | |
| AR-9443-16 | In distribution | |
| AR-9343-18 | In distribution | |
| AR-9301-49CPC | In distribution | |
| AR-9301-51CPC | In distribution | |
| AR-9353-22 | In distribution | |
| AR-9445-17 | In distribution | |
| AR-9343-16 | In distribution | |
| AR-9349-18 | In distribution | |
| AR-9301-01 | In distribution | |
| AR-9301-47CPC | In distribution | |
| AR-9439-16 | In distribution | |
| AR-9300-45CPC | In distribution | |
| AR-9300-43CPC | In distribution | |
| AR-9439-18 | In distribution | |
| AR-9300-41CPC | In distribution | |
| AR-9300-53CPC | In distribution | |
| AR-9301-43CPC | In distribution | |
| AR-9301-02 | In distribution | |
| AR-9355-21 | In distribution | |
| AR-9339-18 | In distribution | |
| AR-9355-23 | In distribution | |
| AR-9445-19 | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183194 | 2019-07-26 |
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.