CirFIX® Cranial Bone Fixation System: Flap Fixator (3 PCS)
CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile (3 PCS)
3manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Ossaware Biotech Co., Ltd., Taiwan |
|---|---|
| FDA product code | GXR |
| Device type | Cover, Burr Hole |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5250 |
| Establishment | Manufacturer |
| 510(k) | K192310 |
| Record published | 2020-09-28 |
| Record revised | 2024-11-12 (version 6) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Delivery box of 4, shipping carton of 16, delivery box of 8, shipping carton of 32, delivery box of 12, shipping carton of 60 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9903.0101.15S | In distribution | |
| 9903.0001.15S | 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 |
|---|---|
| K192310 | 2020-06-03 |
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.