Bioplate®
Flexible Burr Hole Cover - Ø1.9 mm - 18 mm (1), Boxcar - 4 hole - 11 mm (2), Self-Drilling Screw - 4 mm (5) [5 PK]
3manufacturers in China registered for this device type
48catalogue 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 | Bioplate, Inc., United States |
|---|---|
| FDA product code | GXR |
| Device type | Cover, Burr Hole |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5250 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K082757 |
| Record published | 2021-07-13 |
| Record revised | 2025-06-09 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5, pack of 10 |
| Sizes | Length 12 to 24 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 81-7310 | In distribution | ||
| 81-2046-CP | Length 12 mm | 5 | In distribution |
| 81-5770[US] | Length 24 mm | In distribution | |
| 81-5903 | In distribution | ||
| 81-2053[US] | Length 12 mm | In distribution | |
| 81-2055 | Length 12 mm | In distribution | |
| 81-2093 | In distribution | ||
| 81-7366 | In distribution | ||
| 81-5771 | Length 24 mm | In distribution | |
| 81-2053 | Length 12 mm | In distribution | |
| 81-3180-CP | Length 18 mm | 5 | In distribution |
| 81-5768 | Length 24 mm | In distribution | |
| 81-5895 | In distribution | ||
| 81-7368 | In distribution | ||
| 81-3370 | Length 18 mm | In distribution | |
| 81-3593 | In distribution | ||
| 81-2046 | Length 12 mm | In distribution | |
| 81-3372 | Length 18 mm | In distribution | |
| 81-5770-CP | Length 24 mm | 5 | In distribution |
| 81-3180[US] | Length 18 mm | In distribution | |
| 81-7371 | In distribution | ||
| 81-5770 | Length 24 mm | In distribution | |
| 81-2048 | Length 12 mm | In distribution | |
| 81-5733-CP | Length 18 mm | 5 | In distribution |
| 81-2054 | Length 18 mm | In distribution | |
| 81-3580 | In distribution | ||
| 81-2006 | Length 18 mm | In distribution | |
| 81-5771[US] | Length 24 mm | In distribution | |
| 81-2047[US] | Length 18 mm | In distribution | |
| 81-3588 | In distribution | ||
| 81-3356 | Length 19 mm | In distribution | |
| 81-2049[US] | Length 18 mm | In distribution | |
| 81-2046[US] | Length 12 mm | In distribution | |
| 81-2049 | Length 18 mm | In distribution | |
| 81-5894 | In distribution | ||
| 81-2053-CP | Length 12 mm | 5 | In distribution |
| 81-5769 | Length 24 mm | In distribution | |
| 81-7333 | In distribution | ||
| 81-3033 | Length 18 mm | In distribution | |
| 81-2056 | Length 18 mm | In distribution | |
| 81-5771-CP | Length 24 mm | 5 | In distribution |
| 81-3032 | Length 12 mm | In distribution | |
| 81-2047 | Length 18 mm | In distribution | |
| 81-7320 | In distribution | ||
| 81-2054-CP | Length 18 mm | In distribution | |
| 81-3180 | Length 18 mm | In distribution | |
| 81-2005 | Length 12 mm | In distribution | |
| 81-2054[US] | Length 18 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 1.5MM System | Biomet Microfixation | 90 |
| “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 |
| Raas Cranial Plating System | Alliance Partners, LLC | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bioplate, Inc. | 510(k) number | 2010-03-31 | Not classified | Process design | There is potential defect in seal of the sterile barrier containing the device. | 16,020 Individual Kits; 2,226 Boxes. | 2012-04-04 |
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.