DBX®
AFT-DS Straight Tube (7/8-filled)
2manufacturers in China registered for this device type
7catalogue numbers in this listing
9510(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 | Musculoskeletal Transplant Foundation, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Record published | 2016-02-19 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 227060 | In distribution | |
| 428025 | 2.5 cc volume | In distribution |
| 227007 | In distribution | |
| 227010 | In distribution | |
| 227005 | In distribution | |
| 028005 | In distribution | |
| 227055 | 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 |
|---|---|
| K121313 | 2013-01-11 |
| K113167 | 2012-01-24 |
| K110003 | 2011-10-13 |
| K103795 | 2011-04-13 |
| K103784 | 2011-04-13 |
| K091218 | 2009-09-28 |
| K053218 | 2006-12-28 |
| K042125 | 2005-07-28 |
| K040262 | 2005-03-17 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | UDI-DI | 2023-12-22 | Class II | Nonconforming Material/Component | Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues. | 89 |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | UDI-DI | 2023-12-22 | Class II | Nonconforming Material/Component | Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues. | 50 |
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.