Conduct
CONDUCT Matrix Strip, 2x6.25x0.8cm, 10cc (1/box)
2manufacturers in China registered for this device type
8catalogue numbers in this listing
7510(k) clearances naming this product code
1recall
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Manufacturer, Exporter |
| Record published | 2015-11-07 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Total volume 2 to 20 ml; length 2 to 6.25 cm; height 0.5 to 0.8 cm; width 2 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 844.110S | Total Volume 10 ml | In distribution |
| 844.202S | Total Volume 2 ml | In distribution |
| 844.010S | Total Volume 10 ml | In distribution |
| 844.120S | Height 0.8 cm | In distribution |
| 844.204S | Height 0.5 cm | In distribution |
| 844.005S | Total Volume 5 ml | In distribution |
| 844.210S | Width 2 cm | In distribution |
| 844.002S | 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 |
| 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 |
|---|---|
| K133678 | 2014-08-26 |
| K130977 | 2013-12-24 |
| K130392 | 2013-08-15 |
| K102392 | 2010-12-22 |
| K083232 | 2008-12-24 |
| K082442 | 2008-10-07 |
| K071187 | 2007-12-20 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-08-28 | Class II | Process control | The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. | 193 | 2014-11-14 |
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.