Invisx™
Lock 60110 Invisx Shelf PK 10 X 2 PK
3manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), 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 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Medtronic PS Medical, United States |
|---|---|
| FDA product code | GXN |
| Device type | Plate, Cranioplasty, Preformed, Non-Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5330 |
| 510(k) | K010361 |
| Record published | 2015-07-01 |
| Record revised | 2023-04-04 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Ct of 20 |
| Sizes | Width 2.54 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60110 | Width 2.54 mm | In distribution | |
| 60710 | In distribution | ||
| 60700 | In distribution | ||
| 60700 | In distribution | ||
| 60100 | Width 2.54 mm | 2 | In distribution |
| 60730 | In distribution | ||
| 60720 | In distribution | ||
| 60730 | In distribution | ||
| 60710 | In distribution | ||
| 60110 | Width 2.54 mm | In distribution | |
| 60101 | Width 2.54 mm | In distribution | |
| 60720 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HTR-Pekk | Oxford Performance Materials, Inc. | 4,551 |
| Kelyniam CSI | Kelyniam Global Inc. | 1,714 |
| Plate, Cranioplasty, Preformed, Non-Alterable | Synthes Gmbh | 263 |
| PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | Kontour (Xi’an) Medical Technology Co., Ltd. | 162 |
| CranioFit | Bioplate, Inc. | 161 |
| IPS | KLS-Martin L.P. | 74 |
| AccuShape | MedCAD | 27 |
| ClearFit | Longeviti Neuro Solutions | 26 |
| IPS, Sterile | KLS-Martin L.P. | 18 |
| Level ONE Thoracic, Sterile | KLS-Martin L.P. | 14 |
| Meticuly Patient-specific titanium mesh implant | Meticuly Co., Ltd. | 13 |
| Bioplate® | Bioplate, Inc. | 13 |
Showing 12 of 32. All products under Plate, Cranioplasty, Preformed, Non-Alterable
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.