My Knee Tibial Cutting Blocks MIS
MRI Right Medial #2 Sterile
2manufacturers in China registered for this device type
36catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Medacta International SA, Switzerland |
|---|---|
| FDA product code | OOG |
| Device type | Knee Arthroplasty Implantation System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K093806 |
| Record published | 2014-11-18 |
| Record revised | 2023-05-03 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4.1233 | In distribution | |
| 4.1284 | In distribution | |
| 4.2235S | In distribution | |
| 4.1282 | In distribution | |
| 4.2293 | In distribution | |
| 4.1231 | In distribution | |
| 4.2243 | In distribution | |
| 4.1244 | In distribution | |
| 4.1243S | In distribution | |
| 4.2234 | In distribution | |
| 4.2231S | In distribution | |
| 4.2282 | In distribution | |
| 4.2242S | In distribution | |
| 4.1236S | In distribution | |
| 4.1246 | In distribution | |
| 4.2241 | In distribution | |
| 4.2244S | In distribution | |
| 4.2291 | In distribution | |
| 4.2246S | In distribution | |
| 4.1295 | In distribution | |
| 4.2286 | In distribution | |
| 4.2236 | In distribution | |
| 4.2295 | In distribution | |
| 4.1235 | In distribution | |
| 4.1232S | In distribution | |
| 4.2245 | In distribution | |
| 4.1242 | In distribution | |
| 4.2233S | In distribution | |
| 4.1241S | In distribution | |
| 4.1245S | In distribution | |
| 4.1286 | In distribution | |
| 4.1234S | In distribution | |
| 4.1293 | In distribution | |
| 4.2284 | In distribution | |
| 4.2232 | In distribution | |
| 4.1291 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 1,463 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 202 |
| iTotal Identity CR | ConforMIS, Inc. | 138 |
| My Knee Femoral Cutting Blocks | Medacta International SA | 60 |
| iTotal® CR iPoly™ Insert Kit | ConforMIS, Inc. | 59 |
| My Knee Tibial Cutting Blocks | Medacta International SA | 48 |
| My Knee Femoral Cutting Blocks MIS | Medacta International SA | 42 |
| iTotal® Identity Cruciate Retaining Knee Replacement System | ConforMIS, Inc. | 27 |
| iTotal® CR iPoly® XE Insert Kit | ConforMIS, Inc. | 16 |
| Zimmer Patient Specific Instruments | Materialise NV | 12 |
| iTotal Identity CR Knee Replacement System | ConforMIS, Inc. | 12 |
| iTotal® PS iPoly® XE Insert Kit | ConforMIS, Inc. | 11 |
Showing 12 of 95. All products under Knee Arthroplasty Implantation System
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.