OpteMx
Synthetic Resorbable Bone Graft Stick
2manufacturers in China registered for this device type
28catalogue 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 | 2016-05-11 |
| 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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 6 to 12 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 670-10-40 | Stick 10x10x40mm | In distribution |
| 670-03-30 | Granules 2-3mm 30cc | In distribution |
| 670-21-12 | Height 12 mm | In distribution |
| 670-11-02 | Stick 5x5x10mm (x2) | In distribution |
| 670-12-02 | Sticks 5x5x20mm (x2) | In distribution |
| 670-22-06 | Height 6 mm | In distribution |
| 670-02-02 | Granules 1-2mm 2cc | In distribution |
| 670-11-04 | Sticks 5x5x10mm (x4) | In distribution |
| 670-22-10 | Height 10 mm | In distribution |
| 670-30-12 | Cylinder diam. 14 mm – L 20 mm. | In distribution |
| 670-03-02 | Granules 2-3mm 2cc | In distribution |
| 670-21-08 | Height 8 mm | In distribution |
| 670-02-10 | Granules 1-2mm 10cc | In distribution |
| 670-03-16 | Granules 2-3mm 16cc | In distribution |
| 670-30-09 | Cynlinder diam. 9mm – L 20 mm | In distribution |
| 670-10-10 | Stick 10x10x10mm | In distribution |
| 670-22-12 | Height 12 mm | In distribution |
| 670-01-02 | Granules 0,5-1mm 2cc | In distribution |
| 670-30-10 | Cylinder diam. 10 mm – L 20 mm | In distribution |
| 670-30-14 | Cylinder diam. 14 mm – L 20 mm | In distribution |
| 670-03-10 | Granules 2-3mm 10cc | In distribution |
| 670-22-08 | Height 8 mm | In distribution |
| 670-01-01 | Granules 0,5-1mm 1cc | In distribution |
| 670-21-10 | Height 10 mm | In distribution |
| 670-20-50 | Stick 10x20x50mm | In distribution |
| 670-21-06 | Height 6 mm | In distribution |
| 670-30-08 | Cylinder diam. 8 mm – L 20 mm | In distribution |
| 670-12-04 | Sticks 5x5x20mm (x4) | 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.