OssGro
Synthetic Resorbable Bone Graft Granules
2manufacturers in China registered for this device type
23catalogue 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 | 2017-09-22 |
| Record revised | 2023-02-01 (version 5) |
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, manufacturing date, serial number |
| Distribution end date | 2023-01-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LE9801B02 | Stick 5x5x10 (x2) | Withdrawn |
| LE9902G10 | Granules 1-2mm 10cc | Withdrawn |
| LE0803G20 | Granules 2-3mm 20cc | Withdrawn |
| LE9802B04 | Sticks 5x5x20 (x4) | Withdrawn |
| LE0503G05 | Granules 2-3mm 5cc | Withdrawn |
| LE9903G10 | Granules 2-3mm 10cc | Withdrawn |
| LE9801B04 | Sticks 5x5x10 (x4) | Withdrawn |
| LE1102GS10 | Granules 1-2mm 10cc | Withdrawn |
| LE0106C01 | Wedge 6mm | Withdrawn |
| LE9902G02 | Granules 1-2mm 2cc | Withdrawn |
| LE0108C01 | Wedge 8mm | Withdrawn |
| LE9905C01 | Wedge 5mm | Withdrawn |
| LE0112C01 | Wedge 12mm | Withdrawn |
| LE9910C01 | Wedge 10mm | Withdrawn |
| LE9906C01 | Wedge 6mm | Withdrawn |
| LE0110C01 | Wedge 10mm | Withdrawn |
| LE9912C01 | Wedge 12mm | Withdrawn |
| LE0603G30 | Granules 2-3mm 30cc | Withdrawn |
| LE0602G30 | Granules 1-2mm 30cc | Withdrawn |
| LE1414C01 | Wedge 14mm | Withdrawn |
| LE1102GS05 | Granules1-2mm 5cc | Withdrawn |
| LE9802B02 | Sticks 5x5x20 (x2) | Withdrawn |
| LE9908C01 | Wedge 8mm | Withdrawn |
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.