NuROs Bone Graft Substitute(Sterile)
NuROs Absorbable Bone Graft Substitute is an implant intended to fill bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These osseous defects are surgically created…
NuROs Absorbable Bone Graft Substitute is an implant intended to fill bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NuROs Absorbable Bone Graft Substitute is absorbed around 6 months and replaced with bone during the healing process.
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 | Oriental Resources Development Limited Biomedical Factory |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| 510(k) | K140913 |
| Record published | 2019-05-20 |
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, manufacturing date |
| Sizes | Length 3 to 20 mm; total volume 2.5 to 5 ml; depth 5 mm; width 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BGD50 | Length 3 mm | In distribution |
| NBP50 | Block | 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
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.