PRO Osteon 500r
Resorbable Bone Graft Substitute Block, W-Block
2manufacturers in China registered for this device type
24catalogue numbers in this listing
2510(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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5RBW101 | 11 mm X 25 mm X 60 mm Block (10.1 cc) | In distribution |
| 5RB010 | 10 mm x 10 mm x 10 mm Block (1.0 cc) | In distribution |
| 5RG30L | Large Granules (5mm to 9mm Ø) 30cc | In distribution |
| 5RBW180 | 22 mm X 25 mm X 60 mm Block (18.0 cc) | In distribution |
| 5RB040 | 10 mm x 10 mm x 40 mm Block (4.0 cc) | In distribution |
| 5RG15L | Large Granules (5mm to 9mm Ø) 15cc | In distribution |
| 5RB075 | 12 mm x 25 mm x 25 mm Block (7.5 cc) | In distribution |
| 5RG30 | Granules (1mm to 4mm Ø) 30cc | In distribution |
| 5RBW144 | 17 mm X 25 mm X 60 mm Block (14.4 cc) | In distribution |
| 5RB108 | 12 mm x 30 mm x 30 mm Block (10.8 cc) | In distribution |
| 5RG10 | Granules (1mm to 4mm Ø) 10cc | In distribution |
| 5RG05 | Granules (1mm to 4mm Ø) 5cc | In distribution |
| 5RBW072 | 7 mm X 25 mm X 60 mm Block (7.2 cc) | In distribution |
| 5RB014 | 6 mm x 6 mm x 40 mm Block (1.4 cc) | In distribution |
| 5RBW079 | 8 mm X 25 mm X 60 mm Block (7.9 cc) | In distribution |
| 5RBW065 | 6 mm X 25 mm X 60 mm Block (6.5 cc) | In distribution |
| 5RBW130 | 15 mm X 25 mm X 60 mm Block (13.0 cc) | In distribution |
| 5RB024 | 5 mm x 12 mm x 40 mm Block (2.4 cc) | In distribution |
| 5RBW166 | 20 mm X 25 mm X 60 mm Block (16.6 cc) | In distribution |
| 5RBW094 | 10 mm X 25 mm X 60 mm Block (9.4 cc) | In distribution |
| 5RG15 | Granules (1mm to 4mm Ø) 15cc | In distribution |
| 5RB100 | 12 mm x 25 mm x 25 mm Block (7.5 cc) | In distribution |
| 5RBW108 | 12 mm X 25 mm X 60 mm Block (10.8 cc) | In distribution |
| 5RG20 | Granules (1mm to 4mm Ø) 20cc | 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 |
|---|---|
| K032286 | 2003-11-20 |
| K013790 | 2002-06-11 |
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.