Guardian™
Cranial Burr Hole Cover Sys.
3manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(k) clearances naming this product code
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 | St. Jude Medical, United States |
|---|---|
| FDA product code | GXR |
| Device type | Cover, Burr Hole |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5250 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K181382 |
| Record published | 2018-08-24 |
| Record revised | 2025-06-09 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 14 to 131 °F; Storage environment humidity 10 to 90 % RH; Storage environment temperature -10 to 55 °C; Storage environment atmospheric pressure 70 to 150 KiloPascal |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6010 | In distribution | |
| 6015 | In distribution | |
| 6010 | In distribution | |
| 6015 | In distribution |
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 |
| 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 |
Showing 12 of 52. All products under Cover, Burr Hole
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181382 | 2018-07-20 |
| K152342 | 2016-06-09 |
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.