Universal2 Total Wrist Implant System
UNI2 Screw. 4.5MM X 25MM Sterile
1manufacturer
34catalogue 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 | Smith & Nephew, Inc., United States |
|---|---|
| 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, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K030037 |
| Record published | 2022-12-22 |
| 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 |
| Storage | Special storage condition: : – |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 262302 | In distribution | |
| 262101 | In distribution | |
| 264525 | In distribution | |
| 261401 | In distribution | |
| 262301 | In distribution | |
| 263300LF | In distribution | |
| 263300RT | In distribution | |
| 261101 | In distribution | |
| 262401 | In distribution | |
| 262100 | In distribution | |
| 262402 | In distribution | |
| 264525S | In distribution | |
| 264520 | In distribution | |
| 262300 | In distribution | |
| 264535 | In distribution | |
| 262102 | In distribution | |
| 264515 | In distribution | |
| 264515S | In distribution | |
| 262202 | In distribution | |
| 261201 | In distribution | |
| 262201 | In distribution | |
| 264530S | In distribution | |
| 264520S | In distribution | |
| 262400 | In distribution | |
| 263400RT | In distribution | |
| 263100RT | In distribution | |
| 261301 | In distribution | |
| 263200LF | In distribution | |
| 263100LF | In distribution | |
| 263400LF | In distribution | |
| 264530 | In distribution | |
| 263200RT | In distribution | |
| 264535S | In distribution | |
| 262200 | 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 |
| Remotion | Stryker GmbH | 53 |
| Universal 2™ Total Wrist System | Ascension Orthopedics, Inc. | 43 |
| 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.