My Knee Femoral Cutting Blocks MIS
MRI Right Medial #3 Sterile
2manufacturers in China registered for this device type
42catalogue 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 |
|---|---|---|
| 4.1216 | In distribution | |
| 4.1226S | In distribution | |
| 4.2276 | In distribution | |
| 4.2265 | In distribution | |
| 4.2223S | In distribution | |
| 4.2222 | In distribution | |
| 4.1212 | In distribution | |
| 4.1221 | In distribution | |
| 4.2216S | In distribution | |
| 4.2213 | In distribution | |
| 4.2221S | In distribution | |
| 4.2263 | In distribution | |
| 4.1272 | In distribution | |
| 4.2212S | In distribution | |
| 4.1215S | In distribution | |
| 4.1214 | In distribution | |
| 4.1267 | In distribution | |
| 4.2214S | In distribution | |
| 4.1213S | In distribution | |
| 4.1276 | In distribution | |
| 4.1211S | In distribution | |
| 4.1263 | In distribution | |
| 4.2227S | In distribution | |
| 4.2272 | In distribution | |
| 4.2211 | In distribution | |
| 4.1224S | In distribution | |
| 4.1274 | In distribution | |
| 4.2215 | In distribution | |
| 4.1265 | In distribution | |
| 4.2261 | In distribution | |
| 4.2225S | In distribution | |
| 4.2226 | In distribution | |
| 4.2274 | In distribution | |
| 4.1217S | In distribution | |
| 4.1261 | In distribution | |
| 4.1222S | In distribution | |
| 4.1225 | In distribution | |
| 4.1227 | In distribution | |
| 4.2277 | In distribution | |
| 4.1223 | In distribution | |
| 4.2217 | In distribution | |
| 4.2224 | 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 Tibial Cutting Blocks MIS | Medacta International SA | 36 |
| 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.