Integra®
Integra Freedom Wrist System
1manufacturer
1catalogue number
1510(k) clearance
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 | Ascension Orthopedics, 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 | Manufacturer |
| 510(k) | K132250 |
| Record published | 2016-07-25 |
| Record revised | 2023-05-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
| Distribution end date | 2023-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FREEDOMIMP | Withdrawn |
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 |
| Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 34 |
| KinematX | Extremity Medical, LLC | 14 |
| Precise | Stryker GmbH | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233674 | 2024-05-30 |
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.