BIO1-KIT
Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
2manufacturers in China registered for this device type
15catalogue 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 | S.B.M |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| 510(k) | K061022 |
| Record published | 2015-10-13 |
| Record revised | 2020-01-10 (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 | Total volume 5 to 45 ml |
| Distribution end date | 2020-01-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BIO1-KIT pre-loaded syringe with Ø3 mm granules | Total Volume 5 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with 4x4x4mm cubes | Total Volume 45 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with Ø3 mm granules | Total Volume 10 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with Ø1.5 mm granules | Total Volume 5 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with Ø1.5 mm granules | Total Volume 30 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with 4x4x4mm cubes | Total Volume 10 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with 4x4x4mm cubes | Total Volume 15 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with Ø1.5 mm granules | Total Volume 45 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with Ø1.5 mm granules | Total Volume 15 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with Ø3 mm granules | Total Volume 45 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with Ø3 mm granules | Total Volume 30 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with Ø3 mm granules | Total Volume 15 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with 4x4x4mm cubes | Total Volume 5 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with Ø1.5 mm granules | Total Volume 10 ml | Withdrawn |
| BIO1-KIT pre-loaded syringe with 4x4x4mm cubes | Total Volume 30 ml | Withdrawn |
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.