Kinos Axiom Instrumentation
50.8mm x 1.21mm Reciprocating Saw Blade, Synthes
1manufacturer
169catalogue 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) | K232595 |
| Record published | 2024-01-19 |
| Record revised | 2023-11-02 (version 4) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-05-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5801-0101 | In distribution | |
| 5801-9210 | In distribution | |
| 5801-8108 | In distribution | |
| 5801-3109 | In distribution | |
| 5801-7406 | In distribution | |
| 5801-0051 | In distribution | |
| 5801-1076 | In distribution | |
| 5801-1079 | In distribution | |
| 5801-1007 | In distribution | |
| 5801-1004 | In distribution | |
| 5801-0020 | In distribution | |
| 5801-1065 | In distribution | |
| 5801-1018 | In distribution | |
| 5801-0902 | In distribution | |
| 5801-9810 | In distribution | |
| 5801-4064 | In distribution | |
| 5801-7110 | In distribution | |
| 5801-1029 | In distribution | |
| 5801-9106 | In distribution | |
| 5801-0050 | In distribution | |
| 5801-7106 | In distribution | |
| 5801-1071 | In distribution | |
| 5801-3113 | In distribution | |
| 5801-1031 | In distribution | |
| 5801-9406 | In distribution | |
| 5801-1005 | In distribution | |
| 5801-0116 | In distribution | |
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| 5801-2072 | In distribution | |
| 5801-8206 | In distribution | |
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| 5801-8208 | In distribution | |
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| 5801-4062 | In distribution | |
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| 5801-4035 | In distribution | |
| 5801-1014 | Withdrawn | |
| 5801-1020 | Withdrawn | |
| 5801-0901 | Withdrawn | |
| 5801-0013 | Withdrawn |
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 |
| Quantum | In2Bones SAS | 157 |
| Hintermann Series H2 | Vilex LLC | 153 |
| Trabecular Metal® | Zimmer, Inc. | 145 |
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.