My Knee Tibial Cutting Blocks
MRI Right Lateral #6 Sterile
2manufacturers in China registered for this device type
48catalogue 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 |
|---|---|---|
| 4.2093 | In distribution | |
| 4.2082 | In distribution | |
| 4.2096S | In distribution | |
| 4.2041S | In distribution | |
| 4.2045S | In distribution | |
| 4.2091 | In distribution | |
| 4.2042 | In distribution | |
| 4.1046S | In distribution | |
| 4.1032 | In distribution | |
| 4.2036S | In distribution | |
| 4.1043 | In distribution | |
| 4.2094S | In distribution | |
| 4.1084S | In distribution | |
| 4.2034S | In distribution | |
| 4.1034 | In distribution | |
| 4.1085 | In distribution | |
| 4.1035S | In distribution | |
| 4.1086S | In distribution | |
| 4.1092 | In distribution | |
| 4.1045 | In distribution | |
| 4.2092S | In distribution | |
| 4.2084 | In distribution | |
| 4.2044 | In distribution | |
| 4.2035 | In distribution | |
| 4.1082S | In distribution | |
| 4.1044S | In distribution | |
| 4.1095S | In distribution | |
| 4.1083 | In distribution | |
| 4.1096 | In distribution | |
| 4.2043S | In distribution | |
| 4.1042S | In distribution | |
| 4.2031 | In distribution | |
| 4.1036 | In distribution | |
| 4.2083S | In distribution | |
| 4.2033 | In distribution | |
| 4.1033S | In distribution | |
| 4.1091S | In distribution | |
| 4.2032S | In distribution | |
| 4.2081S | In distribution | |
| 4.1094 | In distribution | |
| 4.1081 | In distribution | |
| 4.2086 | In distribution | |
| 4.2095 | In distribution | |
| 4.2046 | In distribution | |
| 4.1041 | In distribution | |
| 4.2085S | In distribution | |
| 4.1093S | In distribution | |
| 4.1031S | 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 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.