LSI Arthroereisis Peg
LSI Implant Medium Plus
1manufacturer
42catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Record
| Listed by | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | MJW |
| Device type | Prosthesis, Subtalar, Plug, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K922292 |
| Record published | 2020-11-24 |
| Record revised | 2025-02-06 (version 4) |
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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TN-LD-9501 | In distribution | |
| SG-LD-0501-S | In distribution | |
| TN-LD-4002 | In distribution | |
| TN-LD-5501 | In distribution | |
| TN-LD-5002 | In distribution | |
| TN-LD-9501 | In distribution | |
| TN-LD-9001 | In distribution | |
| TN-LD-9001 | In distribution | |
| TN-LD-4001 | In distribution | |
| TN-LD-5503 | In distribution | |
| TN-LD-2000 | In distribution | |
| TN-LD-5003 | In distribution | |
| TN-LD-9003 | In distribution | |
| SG-LD-0502-S | In distribution | |
| CD-LD-1050 | In distribution | |
| TN-LD-5001 | In distribution | |
| TN-LD-9003 | In distribution | |
| SG-LD-0003-S | In distribution | |
| TN-LD-5501 | In distribution | |
| TN-LD-5502 | In distribution | |
| TN-LD-5502 | In distribution | |
| SG-LD-0002-S | In distribution | |
| CD-LD-7000 | In distribution | |
| TN-LD-6003 | In distribution | |
| TN-LD-5003 | In distribution | |
| TN-LD-6001 | In distribution | |
| TN-LD-6002 | In distribution | |
| SG-LD-0503-S | In distribution | |
| TN-LD-5001 | In distribution | |
| TN-LD-9002 | In distribution | |
| TN-LD-5002 | In distribution | |
| TN-LD-9503 | In distribution | |
| TN-LD-9002 | In distribution | |
| TN-LD-6002 | In distribution | |
| TN-LD-9502 | In distribution | |
| TN-LD-9503 | In distribution | |
| TN-LD-6003 | In distribution | |
| TN-LD-6001 | In distribution | |
| TN-LD-9502 | In distribution | |
| TN-LD-5503 | In distribution | |
| CD-LD-1000 | In distribution | |
| SG-LD-0001-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| bioBLOCK® Subtalar Implant System | Ascension Orthopedics, Inc. | 3 |
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.