ChronOS
Chronos Beta-TCP Strip MX TWO Strips 47MMX18MMX3MM-STER
2manufacturers in China registered for this device type
39catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Allgens Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 1 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K043045 |
| Record published | 2015-09-14 |
| Record revised | 2026-05-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 25 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 710.039.99S | In distribution | |
| 710.925.99S | In distribution | |
| 710.026.97S | In distribution | |
| 710.014.99S | In distribution | |
| 710.021.99S | In distribution | |
| 710.935.99S | In distribution | |
| 710.051.97S | In distribution | |
| 710.025.97S | In distribution | |
| 710.038.99S | In distribution | |
| 710.922.99S | In distribution | |
| 710.936.99S | In distribution | |
| 710.021.97S | In distribution | |
| 710.047.97S | In distribution | |
| 07.801.110.99S | In distribution | |
| 07.801.200.99S | In distribution | |
| 710.926.99S | In distribution | |
| 710.002.99S | In distribution | |
| 710.921.99S | In distribution | |
| 710.938.99S | In distribution | |
| 710.927.99S | In distribution | |
| 710.027.99S | In distribution | |
| 710.932.99S | In distribution | |
| 710.937.99S | In distribution | |
| 710.931.99S | In distribution | |
| 07.801.111.99S | In distribution | |
| 710.014.97S | In distribution | |
| 710.025.99S | In distribution | |
| 710.924.99S | In distribution | |
| 710.063.97S | In distribution | |
| 07.801.101.99S | In distribution | |
| 710.933.99S | In distribution | |
| 710.060.97S | In distribution | |
| 710.019.99S | In distribution | |
| 07.801.100.99S | In distribution | |
| 710.923.99S | In distribution | |
| 710.026.99S | In distribution | |
| 710.050.97S | In distribution | |
| 710.934.99S | In distribution | |
| 710.928.99S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synthacer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 360 |
| Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 357 |
| Biosorb | S.B.M | 65 |
| MagnetOs | Kuros Biosciences B.V | 61 |
| BioSet® | Rti Surgical, Inc. | 47 |
| Bicera® Resorbable Bone Substitute | Wiltrom Corporation Limited | 41 |
| GRAFTON®and Grafton PLUS®Demineralized Bone Matrix (DBM) | Medtronic Sofamor Danek, Inc. | 40 |
| Bicera® Resorbable Bone Substitute | Wiltrom Co., Ltd. (Chutung) | 39 |
| Synthacer/Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 36 |
| Inion BioRestore™ | Inion OY | 35 |
| Resorba Synthetic Bone | Biomatlante | 35 |
| Cem-Ostetic Putty | Berkeley Advanced Biomaterials | 34 |
Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K013072 | 2002-11-26 |
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.