Remotion
Wrist Carpal Ball Implant, Neutral, Medium
1manufacturer
53catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | JWJ |
| Device type | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2025-04-14 (version 6) |
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 |
| Sizes | Length 15 to 30 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 300-4300 | In distribution | |
| 300-0100 | In distribution | |
| WA/B-NS | In distribution | |
| WA/C-L | In distribution | |
| WA/R-LL | In distribution | |
| 300-1700 | In distribution | |
| 300-4000 | In distribution | |
| 300-4200 | In distribution | |
| WA/R-RM | In distribution | |
| 300-0400 | In distribution | |
| WA/S-15 | Length 15.0 mm | In distribution |
| 300-3700 | In distribution | |
| WA/B-NL | In distribution | |
| WA/B-PL | In distribution | |
| 300-2800 | In distribution | |
| 300-3800 | In distribution | |
| 300-1800 | In distribution | |
| 300-1000 | In distribution | |
| 300-0900 | In distribution | |
| 300-2900 | In distribution | |
| WA/R-LXS | In distribution | |
| 300-4700 | In distribution | |
| 300-4500 | In distribution | |
| 300-0200 | In distribution | |
| WA/B-NM | In distribution | |
| WA/B-PS | In distribution | |
| WA/R-LM | In distribution | |
| 300-2600 | In distribution | |
| 300-3900 | In distribution | |
| 300-4400 | In distribution | |
| WA/C-S | In distribution | |
| 300-1900 | In distribution | |
| WA/R-RXS | In distribution | |
| WA/S-22 | Length 22.0 mm | In distribution |
| WA/R-RL | In distribution | |
| 300-4100 | In distribution | |
| WA/S-26 | Length 26.0 mm | In distribution |
| WA/C-M | In distribution | |
| 300-2700 | In distribution | |
| WA/B-PM | In distribution | |
| WA/S-30 | Length 30.0 mm | In distribution |
| WA/S-18 | Length 18.0 mm | In distribution |
| 300-5000 | In distribution | |
| WA/R-RS | In distribution | |
| 300-0500 | In distribution | |
| 300-4800 | In distribution | |
| 300-4900 | In distribution | |
| 300-1600 | In distribution | |
| 300-1100 | In distribution | |
| 300-3600 | In distribution | |
| WA/R-LS | In distribution | |
| 300-0800 | In distribution | |
| 300-4600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maestro Total Wrist | Biomet Orthopedics | 136 |
| Freedom Wrist Arthroplasty System | Smith & Nephew, Inc. | 70 |
| Integra® Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | 70 |
| Universal 2™ Total Wrist System | Ascension Orthopedics, Inc. | 43 |
| Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 34 |
| KinematX | Extremity Medical, LLC | 14 |
| Integra® | Ascension Orthopedics, Inc. | 1 |
| Precise | Stryker GmbH | 1 |
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.