Bicera® Resorbable Bone Substitute
Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). Bicera®…
Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
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 | Wiltrom Co., Ltd. (Chutung) |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| 510(k) | K172237 |
| Record published | 2019-09-10 |
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 |
| Storage | Storage environment temperature 23 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BC-G03(0.5-1.0mm,5c.c.) | In distribution | |
| BC-G01(2.0-3.0mm,5c.c.) | In distribution | |
| BC-G13(0.5-1.0mm,0.25g) | In distribution | |
| BC-G09(0.5-1.0mm,10c.c.) | In distribution | |
| BC-G23(0.5-1.0mm,2c.c.) | In distribution | |
| BC-B01(5x5x20mm,2c.c.) | In distribution | |
| BC-G25(1.0-2.0mm,20c.c.) | In distribution | |
| BC-G19 (1.0-2.0mm,1.5g) | In distribution | |
| BC-G27(2.0-3.0mm,15c.c.) | In distribution | |
| BC-G08(0.5-1.0mm,7c.c.) | In distribution | |
| BC-B08 (5x5x20mm,10c.c.) | In distribution | |
| BC-G02(1.0-2.0mm,5c.c.) | In distribution | |
| BC-G20(2.0-3.0mm,0.25g) | In distribution | |
| BC-B11 (5x5x10mm,20c.c.) | In distribution | |
| BC-B03(5x5x10mm,5c.c.) | In distribution | |
| BC-G17(1.0-2.0mm,0.5g) | In distribution | |
| BC-B02(5x5x10mm,2c.c.) | In distribution | |
| BC-G06(1.0-2.0mm,7c.c.) | In distribution | |
| BC-B04(5x5x10mm,7c.c.) | In distribution | |
| BC-G07(1.0-2.0mm,10c.c.) | In distribution | |
| BC-B07(5x5x20mm,7c.c.) | In distribution | |
| BC-G18(1.0-2.0mm,1.0g) | In distribution | |
| BC-B05(5x5x10mm,10c.c.) | In distribution | |
| BC-G16(1.0-2.0mm,0.25g) | In distribution | |
| BC-G26(1.0-2.0mm,30c.c.) | In distribution | |
| BC-G12(0.25-0.5mm,1g) | In distribution | |
| BC-G04(2.0-3.0mm,7c.c.) | In distribution | |
| BC-G28(2.0-3.0mm,20c.c.) | In distribution | |
| BC-G29(2.0-3.0mm,30c.c.) | In distribution | |
| BC-G24(1.0-2.0mm,15c.c.) | In distribution | |
| BC-B10 (5x5x20mm,30c.c.) | In distribution | |
| BC-B09 (5x5x20mm,20c.c.) | In distribution | |
| BC-G22(1.0-2.0mm,2c.c.) | In distribution | |
| BC-G05(2.0-3.0mm,10c.c.) | In distribution | |
| BC-B06(5x5x20mm,5c.c.) | In distribution | |
| BC-G15(0.5-1.0mm,1g) | In distribution | |
| BC-G14(0.5-1.0mm,0.5g) | In distribution | |
| BC-B12 (5x5x10mm,30c.c.) | In distribution | |
| BC-G11(0.25-0.5mm,0.5g) | 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 |
| ChronOS | Synthes Gmbh | 39 |
| Synthacer/Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 36 |
| 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.