Mbcp
Synthetic Bone Substitute Granules 0.5-1mm 3.15 cm3
2manufacturers in China registered for this device type
33catalogue numbers in this listing
5510(k) clearances naming this product code
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 | Biomatlante, France |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Manufacturer |
| 510(k) | K051774 |
| Record published | 2020-04-29 |
| Record revised | 2020-06-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Sizes | Length 6 to 20 mm; total volume 2 to 30 ml; height 10 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0602G30 | Total Volume 30 ml | In distribution |
| 9801B02 | In distribution | |
| 0830B01 | In distribution | |
| 9801B04 | In distribution | |
| 0825B01 | In distribution | |
| 0409D01 | Length 20 mm | In distribution |
| 9910C01 | In distribution | |
| 1102GS05 | 1-2mm 5cc | In distribution |
| 0810B01 | Height 10 cm | In distribution |
| 0850B01 | In distribution | |
| 9802B04 | In distribution | |
| 0108C01 | Length 8 mm | In distribution |
| 9906C01 | In distribution | |
| 0603G30 | Total Volume 30 ml | In distribution |
| 0940B01 | In distribution | |
| 0414D01 | Length 20 mm | In distribution |
| 1102GS10 | 1-2mm 10cc | In distribution |
| 0112C01 | Length 12 mm | In distribution |
| 0503G05 | Total Volume 5 ml | In distribution |
| 9903G02 | Total Volume 2 ml | In distribution |
| 0412D01 | Length 20 mm | In distribution |
| 0110C01 | Length 10 mm | In distribution |
| 9903G16 | In distribution | |
| 0408D01 | Length 20 mm | In distribution |
| 9905C01 | In distribution | |
| 0410D01 | Length 20 mm | In distribution |
| 2301G03 | In distribution | |
| 9908C01 | In distribution | |
| 9802B02 | In distribution | |
| 0106C01 | Length 6 mm | In distribution |
| 9912C01 | In distribution | |
| 9903G10 | In distribution | |
| 0802G05 | Total Volume 5 ml | 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 |
|---|---|
| K071121 | 2007-09-11 |
| K063527 | 2007-07-30 |
| K051774 | 2006-01-20 |
| K043005 | 2005-05-03 |
| K032268 | 2003-12-11 |
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.