My Knee Femoral Cutting Blocks
MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-RM-#7
2manufacturers in China registered for this device type
60catalogue 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 | 2021-04-06 |
| 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 |
|---|---|---|
| 6227 | In distribution | |
| 4.1063S | In distribution | |
| 4.2071S | In distribution | |
| 4.1026 | In distribution | |
| 4.1024 | In distribution | |
| 4.1011 | In distribution | |
| 4.1027S | In distribution | |
| 4.2021 | In distribution | |
| 4.2026S | In distribution | |
| 4.1061S | In distribution | |
| 4.2023 | In distribution | |
| 4.2013S | In distribution | |
| 4.1065S | In distribution | |
| 4.2016 | In distribution | |
| 6320 | In distribution | |
| 4.1066 | In distribution | |
| 4.2024S | In distribution | |
| 4.2014 | In distribution | |
| 4.1016S | In distribution | |
| 4.2067 | In distribution | |
| 4.1072S | In distribution | |
| 6.3627 | In distribution | |
| 4.1017 | In distribution | |
| 4.2065 | In distribution | |
| 4.1077 | In distribution | |
| 4.2073 | In distribution | |
| 4.2062S | In distribution | |
| 4.1071 | In distribution | |
| 4.1015 | In distribution | |
| 4.2011S | In distribution | |
| 4.2012 | In distribution | |
| 4.2077S | In distribution | |
| 4.1076S | In distribution | |
| 4.1021S | In distribution | |
| 4.2017S | In distribution | |
| 4.2066S | In distribution | |
| 4.1074S | In distribution | |
| 4.2061 | In distribution | |
| 4.2022S | In distribution | |
| 4.2075 | In distribution | |
| 4.2063 | In distribution | |
| 4.1025S | In distribution | |
| 4.1014S | In distribution | |
| 4.2072 | In distribution | |
| 4.1062 | In distribution | |
| 6.1021 | In distribution | |
| 4.1013 | In distribution | |
| 4.1064 | In distribution | |
| 4.1023S | In distribution | |
| 4.2075S | In distribution | |
| 4.1012S | In distribution | |
| 4.1067S | In distribution | |
| 4.2025 | In distribution | |
| 4.1022 | In distribution | |
| 4.2064S | In distribution | |
| 4.2015S | In distribution | |
| 4.1075 | In distribution | |
| 4.1073 | In distribution | |
| 4.2073S | In distribution | |
| 4.2027 | 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 |
| 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 |
| 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.