Link Instruments – Trial Implants and Size Gauges
Knee tibia prosthesis trial, reusable - Endo Model Knee System
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | JDT |
| Device type | Cap, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 888.3000 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-2535/16 | In distribution | |
| 15-2535/12 | In distribution | |
| 15-2535/14 | In distribution | |
| 15-2535/01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| FibFix | Fusion Orthopedics, LLC | 15 |
| Metalogix Revolution | Fusion Orthopedics, LLC | 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.