Raas Cranial Plating System
Cranial 1.7x6mm Self-Tapping Rescue Screw
3manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 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 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Alliance Partners, LLC, United States |
|---|---|
| FDA product code | GXR |
| Device type | Cover, Burr Hole |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5250 |
| 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 6 to 90 mm; height 0.3 to 0.5 mm; width 45 to 90 mm; outer diameter 1.7 mm |
| Distribution end date | 2015-12-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2900I-1121 | Outer Diameter 1.7 mm | Withdrawn |
| 2900I-1030 | Height 0.5 mm | Withdrawn |
| 2900I-1201 | Length 90 mm | Withdrawn |
| 2900I-1080 | Length 25 mm | Withdrawn |
| 2900I-1060 | Thickness (Height) of Plate | Withdrawn |
| 2900I-1002 | Length of Plate | Withdrawn |
| 2900I-1071 | Length of Plate | Withdrawn |
| 2900I-1200 | Height 0.3 mm | Withdrawn |
| 2900I-1022 | Thickness (Height) of Plate | Withdrawn |
| 2900I-1003 | Length of Plate | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 1.5MM System | Biomet Microfixation | 90 |
| Bioplate® | Bioplate, Inc. | 48 |
| “2.0MM” System | Biomet Microfixation | 34 |
| Cover, Burr Hole | Biomet Microfixation | 21 |
| Cover, Burr Hole | Synthes Gmbh | 14 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 12 |
| Cover, Burr Hole | Medtronic, Inc. | 11 |
| “1.0MM” System | Biomet Microfixation | 10 |
| Thinflap System | Biomet Microfixation | 7 |
| Neuro System | Biomet Microfixation | 7 |
| 1.5MM System – Craniocurve (TM) Mesh | Biomet Microfixation | 7 |
| Neuro & Craniofacial Fixation System | Inno-Health Technology Co., Ltd. | 6 |
Showing 12 of 52. All products under Cover, Burr Hole
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.