Cover, Burr Hole
Accy 3550S-02 Stimloc Dispsbl Screwdrver
3manufacturers in China registered for this device type
11catalogue 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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | GXR |
| Device type | Cover, Burr Hole |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5250 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K001096 |
| Record published | 2021-10-24 |
| Record revised | 2025-10-09 (version 7) |
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 |
| Storage | Storage environment temperature -34 to 57 °C; Storage environment temperature -30 to 135 °F |
| Distribution end date | 2025-10-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DB-5000 | 5 | In distribution | |
| 3550S-01 | In distribution | ||
| SR-6000 | 6 | In distribution | |
| SR-6000 | 6 | In distribution | |
| 3550S-01 | In distribution | ||
| 3550S-02 | In distribution | ||
| 3550S-02 | Withdrawn | ||
| SR-6000 | 6 | Withdrawn | |
| 3550S-02 | Withdrawn | ||
| 3550S-01 | Withdrawn | ||
| DB-5000 | 5 | Withdrawn |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 |
| “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 |
|---|---|---|---|---|---|---|
| Medtronic Neuromodulation | 510(k) number | 2021-06-02 | Class II | Process control | Excess nylon flash on the clip. | 15,192 |
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.