Zavation
UNIFUZE 20cc 2-Level Block (1 long block/box), 12.5 x 2 x 0.4cm thickness
2manufacturers in China registered for this device type
27catalogue 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 | Zavation, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K052812 |
| Record published | 2019-01-19 |
| Record revised | 2024-04-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 802-0020 | In distribution | |
| 801-0005 | In distribution | |
| 804-0025 | In distribution | |
| 821-102508 | In distribution | |
| 810-001025 | In distribution | |
| 804-0005 | In distribution | |
| 803-0002 | In distribution | |
| 810-001050 | In distribution | |
| 803-0005 | In distribution | |
| 801-0020 | In distribution | |
| 821-502504 | In distribution | |
| 02-030-03-ZVG | In distribution | |
| 821-252504 | In distribution | |
| 800-0004 | In distribution | |
| 802-0005 | In distribution | |
| 803-0010 | In distribution | |
| 801-0010 | In distribution | |
| 821-502508 | In distribution | |
| 800-0002 | In distribution | |
| 805-0010 | In distribution | |
| 805-0005 | In distribution | |
| 805-0020 | In distribution | |
| 810-001100 | In distribution | |
| 802-0010 | In distribution | |
| 800-0010 | In distribution | |
| 821-102504 | In distribution | |
| 821-252508 | 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.