Kinos Instrumentation
Anatomic Flat-Cut Surface Trial, Right, Size 2
1manufacturer
87catalogue numbers in this listing
5510(k) clearances naming this product code
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 |
|---|---|---|---|---|
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | restor3d, inc., United States |
|---|---|
| FDA product code | HSN |
| Device type | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3110 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K240591 |
| Record published | 2024-06-25 |
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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5801-1210 | In distribution | |
| 5801-1111 | In distribution | |
| 5801-4111 | In distribution | |
| 5801-7016 | In distribution | |
| 5801-9200 | In distribution | |
| 5801-1140 | In distribution | |
| 5801-7013 | In distribution | |
| 5801-1212 | In distribution | |
| 5801-1213 | In distribution | |
| 5801-2212 | In distribution | |
| 5801-9824 | In distribution | |
| 5801-1113 | In distribution | |
| 5801-7007 | In distribution | |
| 5801-7414 | In distribution | |
| 5801-9822 | In distribution | |
| 5801-2110 | In distribution | |
| 5801-7006 | In distribution | |
| 5871-2723 | In distribution | |
| 5801-2211 | In distribution | |
| 5801-1220 | In distribution | |
| 5801-9828 | In distribution | |
| 5871-2713 | In distribution | |
| 5801-2114 | In distribution | |
| 5801-2122 | In distribution | |
| 5801-9300 | In distribution | |
| 5801-9825 | In distribution | |
| 5801-9400 | In distribution | |
| 5801-2221 | In distribution | |
| 5801-9100 | In distribution | |
| 5801-7015 | In distribution | |
| 5801-9826 | In distribution | |
| 5871-2720 | In distribution | |
| 5801-7009 | In distribution | |
| 5801-1211 | In distribution | |
| 5801-1110 | In distribution | |
| 5801-1122 | In distribution | |
| 5801-9821 | In distribution | |
| 5801-2120 | In distribution | |
| 5801-1221 | In distribution | |
| 5801-2210 | In distribution | |
| 5801-2124 | In distribution | |
| 5801-7114 | In distribution | |
| 5801-2112 | In distribution | |
| 5801-1114 | In distribution | |
| 5801-7011 | In distribution | |
| 5871-2710 | In distribution | |
| 5871-2722 | In distribution | |
| 5871-2711 | In distribution | |
| 5801-2214 | In distribution | |
| 5801-8100 | In distribution | |
| 5801-8200 | In distribution | |
| 5801-7214 | In distribution | |
| 5801-1222 | In distribution | |
| 5801-1121 | In distribution | |
| 5801-1214 | In distribution | |
| 5801-2123 | In distribution | |
| 5801-2111 | In distribution | |
| 5801-2070 | In distribution | |
| 5801-7314 | In distribution | |
| 5801-9823 | In distribution | |
| 5801-2223 | In distribution | |
| 5801-1224 | In distribution | |
| 5801-7012 | In distribution | |
| 5871-2724 | In distribution | |
| 5801-8400 | In distribution | |
| 5801-2220 | In distribution | |
| 5801-7014 | In distribution | |
| 5801-1124 | In distribution | |
| 5801-1120 | In distribution | |
| 5801-2222 | In distribution | |
| 5801-2224 | In distribution | |
| 5801-1050 | In distribution | |
| 5801-2213 | In distribution | |
| 5801-2121 | In distribution | |
| 5801-9827 | In distribution | |
| 5801-2113 | In distribution | |
| 5801-1123 | In distribution | |
| 5801-1070 | In distribution | |
| 5801-1112 | In distribution | |
| 5871-2721 | In distribution | |
| 5871-2714 | In distribution | |
| 5871-2712 | In distribution | |
| 5801-7010 | In distribution | |
| 5801-7008 | In distribution | |
| 5801-9820 | In distribution | |
| 5801-1223 | In distribution | |
| 5801-8300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apex 3D Total Ankle Replacement System | Paragon 28 | 658 |
| Vantage | Exactech, Inc. | 362 |
| Cadence™ | Ascension Orthopedics, Inc. | 248 |
| Cadence Total Ankle System | Smith & Nephew, Inc. | 246 |
| Inbone | Wright Medical Technology, Inc. | 236 |
| Hintermann Series H2 | DT Medtech LLC | 225 |
| Infinity | Wright Medical Technology, Inc. | 220 |
| Incompass Total Ankle System | Wright Medical Technology, Inc. | 213 |
| Invision | Wright Medical Technology, Inc. | 186 |
| Kinos Axiom Instrumentation | restor3d, inc. | 169 |
| Quantum | In2Bones SAS | 157 |
| Hintermann Series H2 | Vilex LLC | 153 |
Showing 12 of 53. All products under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252454 | 2025-09-03 |
| K242868 | 2024-10-18 |
| K241482 | 2024-07-22 |
| K240591 | 2024-04-29 |
| K232595 | 2023-11-28 |
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.