Vitoss BA2X
4 catalogue numbers from 2102-2105, listed by Stryker GmbH, Switzerland, under Filler, Bone Void, Calcium Compound. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
4catalogue 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K102545 |
| Record published | 2015-09-24 |
| Record revised | 2020-11-03 (version 4) |
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 | Special storage condition: Ambient; Special storage condition: Do Not Freeze; Special storage condition: Do Not Expose to Extreme Heat; Storage environment temperature 15 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2102-2105 | Total Volume: 5.0 Cubic Centimeter | In distribution |
| 2102-2101 | Total Volume: 1.2 Cubic Centimeter | In distribution |
| 2102-2102 | Total Volume: 2.5 Cubic Centimeter | In distribution |
| 2102-2110 | Total Volume: 10.0 Cubic Centimeter | 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 |
| ChronOS | Synthes Gmbh | 39 |
| Synthacer/Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 36 |
| Inion BioRestore™ | Inion OY | 35 |
| Resorba Synthetic Bone | Biomatlante | 35 |
Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060061 | 2006-03-01 |
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.