Synthacer/Syntricer
Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6 mm, 20 ml
2manufacturers in China registered for this device type
36catalogue numbers in this listing
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 | medArtis Medizinprodukte und Forschung Aktiengesellschaft |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| 510(k) | K041177 |
| Record published | 2015-10-24 |
| 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 |
| Sizes | Pore size 300 to 600 µm; total volume 0.5 to 30 ml; outer diameter 1.5 to 6 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T672CB06-5-1 | Outer Diameter 6 mm | In distribution |
| T672G02-2-1 | Pore Size 600 µm | In distribution |
| T671CB15-05-1 | Total Volume 0.5 ml | In distribution |
| T672G03-1-1 | Pore Size 600 µm | In distribution |
| T672G01-2-1 | Particle Size 0.1 – 0.9 mm | In distribution |
| T672CB0406-5-1 | Outer Diameter 6 mm | In distribution |
| T672G02-10-1 | Pore Size 600 µm | In distribution |
| T671CB15-1-1 | Outer Diameter 1.5 mm | In distribution |
| T672G01-20-1 | Pore Size 600 µm | In distribution |
| T672G03-20-1 | Pore Size 600 µm | In distribution |
| T672G03-15-1 | Pore Size 600 µm | In distribution |
| T672G03-30-1 | Pore Size 600 µm | In distribution |
| T671CB15-3-1 | Total Volume 3 ml | In distribution |
| T672G03-5-1 | Particle Size 2.6 – 4.8 mm | In distribution |
| T672G02-30-1 | Particle Size 1.0 – 2.5 mm | In distribution |
| T672G03-2-1 | Particle Size 2.6 – 4.8 mm | In distribution |
| T672CB04-10-1 | Outer Diameter 4 mm | In distribution |
| T672G02-15-1 | Particle Size 1.0 – 2.5 mm | In distribution |
| T672CB06-10-1 | Total Volume 10 ml | In distribution |
| T672CB03-5-1 | Total Volume 5 ml | In distribution |
| T672CB0406-20-1 | Outer Diameter 6 mm | In distribution |
| T672G02-5-1 | Particle Size 1.0 – 2.5 mm | In distribution |
| T672CB04-5-1 | Total Volume 5 ml | In distribution |
| T672G02-1-1 | Particle Size 1.0 – 2.5 mm | In distribution |
| T672G01-10-1 | Particle Size 0.1 – 0.9 mm | In distribution |
| T672G01-1-1 | Pore Size 600 µm | In distribution |
| T672G02-20-1 | Particle Size 1.0 – 2.5 mm | In distribution |
| T672G01-15-1 | Pore Size 600 µm | In distribution |
| T672CB03-2-1 | Total Volume 2 ml | In distribution |
| T672CB03-1-1 | Outer Diameter 3 mm | In distribution |
| T672CB0406-30-1 | Outer Diameter 6 mm | In distribution |
| T672CB0406-10-1 | Total Volume 10 ml | In distribution |
| T672G03-10-1 | Particle Size 2.6 – 4.8 mm | In distribution |
| T672G01-30-1 | Pore Size 600 µm | In distribution |
| T672G01-5-1 | Pore Size 600 µm | In distribution |
| T671CB15-2-1 | Total Volume 2 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 |
| Inion BioRestore™ | Inion OY | 35 |
| Resorba Synthetic Bone | Biomatlante | 35 |
| Cem-Ostetic Putty | Berkeley Advanced Biomaterials | 34 |
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.