Vitoss BA
Bioactive Bone Graft Substitute, Foam Strip; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass
2manufacturers in China registered for this device type
8catalogue 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) | K081439 |
| 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: Do Not Freeze; Special storage condition: Ambient; Special storage condition: Do Not Expose to Extreme Heat; Storage environment temperature 15 to 25 °C |
| Sizes | Width 25 mm; height 4 to 8 mm; length 50 to 100 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2102-1610 | Total Volume: 10.0 Cubic Centimeter | In distribution |
| 2102-1605 | Total Volume: 5.0 Cubic Centimeter | In distribution |
| 2102-1602 | Total Volume: 2.5 Cubic Centimeter | In distribution |
| 2102-1510 | Width 25.0 mm | In distribution |
| 2102-1520 | Width 25.0 mm | In distribution |
| 2102-1601 | Total Volume: 1.2 Cubic Centimeter | In distribution |
| 2102-1505 | Width 25.0 mm | In distribution |
| 2102-1500 | Length 100.0 mm | 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.