Raas Cranial Plating System
Cranial 120x120x0.6mm Dynamic Mesh Plate
3manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Quanzhou Apex Hygiene Products Co., Ltd. | Jinjiang | Fujian | Manufacturer | 8 |
Record
| Listed by | Alliance Partners, LLC, United States |
|---|---|
| FDA product code | HBW |
| Device type | Fastener, Plate, Cranioplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5360 |
| Record published | 2015-09-18 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 4 to 120 mm; height 0.5 to 0.6 mm; width 12 to 120 mm; outer diameter 1.5 mm |
| Distribution end date | 2015-12-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2900I-1211 | Length of Plate | Withdrawn |
| 2900I-1001 | Length of Plate | Withdrawn |
| 2900I-1111 | Outer Diameter 1.5 mm | Withdrawn |
| 2900I-1000 | Thickness (Height) of Plate | Withdrawn |
| 2900I-1031 | Length of Plate | Withdrawn |
| 2900I-1110 | Length 4 mm | Withdrawn |
| 2900I-1040 | Thickness (Height) of Plate | Withdrawn |
| 2900I-1070 | Height 0.5 mm | Withdrawn |
| 2900I-1101 | Length 5 mm | Withdrawn |
| 2900I-1210 | Width 90 mm | Withdrawn |
| 2900I-1021 | Length of Plate | Withdrawn |
| 2900I-1090 | Length of Plate | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 1.5MM System | Biomet Microfixation | 87 |
| Neuro Plating System | Osteonic Co., Ltd. | 55 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 40 |
| “2.0MM” System | Biomet Microfixation | 26 |
| Resorb XG, Sterile | KLS-Martin L.P. | 18 |
| Leforte Neuro System Bone Plate | Jeil Medical Corporation | 15 |
| CMF System | Biomet Microfixation | 14 |
| Fastener, Plate, Cranioplasty | Biomet Microfixation | 14 |
| AXS | Stryker Leibinger Gmbh & Co. KG | 14 |
| Thinflap System | Biomet Microfixation | 12 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 11 |
| NeuroPro® Low Profile | Kinamed, Inc. | 10 |
Showing 12 of 45. All products under Fastener, Plate, Cranioplasty
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.