CranioFit
CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
3manufacturers in China registered for this device type
161catalogue numbers in this listing
5510(k) clearances naming this product code
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 | Bioplate, Inc., United States |
|---|---|
| FDA product code | GXN |
| Device type | Plate, Cranioplasty, Preformed, Non-Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5330 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-10-10 |
| Record revised | 2025-06-09 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KT-T4L12H2 | In distribution | |
| KT-T7L2H1 | In distribution | |
| KT-T8L11H2 | In distribution | |
| KT-T9L15H2 | In distribution | |
| KT-T4L11H2 | In distribution | |
| KT-T2L14H2 | In distribution | |
| KT-T8L14H2 | In distribution | |
| KT-T5L3H1 | In distribution | |
| KT-T2L13H2 | In distribution | |
| KT-T7L1H1 | In distribution | |
| KT-T9L2H1 | In distribution | |
| KT-T1L7H1 | In distribution | |
| KT-T7L5H1 | In distribution | |
| KT-T8L2H1 | In distribution | |
| KT-T8L10H2 | In distribution | |
| KT-T1L15H2 | In distribution | |
| KT-T4L9H2 | In distribution | |
| KT-T2L17H2 | In distribution | |
| KT-T1L4H1 | In distribution | |
| KT-T2L3H1 | In distribution | |
| KT-T5L11H2 | In distribution | |
| KT-T2L2H1 | In distribution | |
| KT-T4L8H2 | In distribution | |
| KT-T7L6H1 | In distribution | |
| KT-T1L18H1 | In distribution | |
| KT-T7L14H2 | In distribution | |
| KT-T2L10H2 | In distribution | |
| KT-T5L14H2 | In distribution | |
| KT-T3L5H1 | In distribution | |
| KT-T3L18H1 | In distribution | |
| KT-T8L16H2 | In distribution | |
| KT-T2L8H2 | In distribution | |
| KT-T1L6H1 | In distribution | |
| KT-T9L4H1 | In distribution | |
| KT-T9L11H2 | In distribution | |
| KT-T2L11H2 | In distribution | |
| KT-T5L10H2 | In distribution | |
| KT-T3L8H2 | In distribution | |
| KT-T3L16H2 | In distribution | |
| KT-T5L17H2 | In distribution | |
| KT-T7L17H2 | In distribution | |
| KT-T4L14H2 | In distribution | |
| KT-T9L18H1 | In distribution | |
| KT-T7L8H2 | In distribution | |
| KT-T6L8H2 | In distribution | |
| KT-T1L3H1 | In distribution | |
| KT-T1L17H2 | In distribution | |
| KT-T1L16H2 | In distribution | |
| KT-T3L14H2 | In distribution | |
| KT-T2L7H1 | In distribution | |
| KT-T4L3H1 | In distribution | |
| KT-T7L13H2 | In distribution | |
| KT-T2L9H2 | In distribution | |
| KT-T7L3H1 | In distribution | |
| KT-T7L9H2 | In distribution | |
| KT-T1L10H2 | In distribution | |
| KT-T8L7H1 | In distribution | |
| KT-T5L18H1 | In distribution | |
| KT-T3L6H1 | In distribution | |
| KT-T8L8H2 | In distribution | |
| KT-T9L12H2 | In distribution | |
| KT-T3L1H1 | In distribution | |
| KT-T3L7H1 | In distribution | |
| KT-T1L14H2 | In distribution | |
| KT-T8L18H1 | In distribution | |
| KT-T8L9H2 | In distribution | |
| KT-T4L16H2 | In distribution | |
| KT-T5L1H1 | In distribution | |
| KT-T3L11H2 | In distribution | |
| KT-T1L9H2 | In distribution | |
| KT-T5L8H2 | In distribution | |
| KT-T9L9H2 | In distribution | |
| KT-T9L14H2 | In distribution | |
| KT-T1L5H1 | In distribution | |
| KT-T2L16H2 | In distribution | |
| KT-T6L14H2 | In distribution | |
| KT-T5L12H2 | In distribution | |
| KT-T8L3H1 | In distribution | |
| KT-T9L7H1 | In distribution | |
| KT-T7L18H1 | In distribution | |
| KT-T2L4H1 | In distribution | |
| KT-T2L18H1 | In distribution | |
| KT-T4L6H1 | In distribution | |
| KT-T8L6H1 | In distribution | |
| KT-T7L7H1 | In distribution | |
| KT-T5L5H1 | In distribution | |
| KT-T7L10H2 | In distribution | |
| KT-T3L2H1 | In distribution | |
| KT-T6L7H1 | In distribution | |
| KT-T6L3H1 | In distribution | |
| KT-T3L13H2 | In distribution | |
| KT-T6L15H2 | In distribution | |
| KT-T8L4H1 | In distribution | |
| KT-T6L1H1 | In distribution | |
| KT-T7L12H2 | In distribution | |
| KT-T8L5H1 | In distribution | |
| KT-T3L15H2 | In distribution | |
| KT-T7L16H2 | In distribution | |
| KT-T5L2H1 | In distribution | |
| KT-T2L5H1 | In distribution | |
| KT-T6L10H2 | In distribution | |
| KT-T4L15H2 | In distribution | |
| KT-T9L16H2 | In distribution | |
| KT-T6L13H2 | In distribution | |
| KT-T8L12H2 | In distribution | |
| KT-T9L5H1 | In distribution | |
| KT-T8L17H2 | In distribution | |
| KT-T1L2H1 | In distribution | |
| KT-T6L17H2 | In distribution | |
| KT-T1L12H2 | In distribution | |
| KT-T4L2H1 | In distribution | |
| KT-T4L18H1 | In distribution | |
| KT-T1L1H1 | In distribution | |
| KT-T9L8H2 | In distribution | |
| KT-T7L11H2 | In distribution | |
| KT-T4L10H2 | In distribution | |
| KT-T3L17H2 | In distribution | |
| KT-T1L11H2 | In distribution | |
| KT-T3L9H2 | In distribution | |
| KT-T5L13H2 | In distribution | |
| KT-T7L15H2 | In distribution | |
| KT-T5L9H2 | In distribution | |
| KT-T3L10H2 | In distribution | |
| KT-T1L8H2 | In distribution | |
| KT-T2L15H2 | In distribution | |
| KT-T8L13H2 | In distribution | |
| KT-T9L6H1 | In distribution | |
| KT-T8L1H1 | In distribution | |
| KT-T5L4H1 | In distribution | |
| KT-T4L1H1 | In distribution | |
| KT-T7L4H1 | In distribution | |
| KT-T6L11H2 | In distribution | |
| KT-T9L1H1 | In distribution | |
| KT-T6L18H1 | In distribution | |
| KT-T5L7H1 | In distribution | |
| KT-T8L15H2 | In distribution | |
| KT-T5L6H1 | In distribution | |
| KT-T9L10H2 | In distribution | |
| KT-T1L13H2 | In distribution | |
| KT-T6L4H1 | In distribution | |
| KT-T5L15H2 | In distribution | |
| KT-T5L16H2 | In distribution | |
| KT-T6L6H1 | In distribution | |
| KT-T4L13H2 | In distribution | |
| KT-T6L16H2 | In distribution | |
| KT-T2L6H1 | In distribution | |
| KT-T4L7H1 | In distribution | |
| KT-T6L2H1 | In distribution | |
| KT-T6L12H2 | In distribution | |
| KT-T9L17H2 | In distribution | |
| KT-T3L3H1 | In distribution | |
| KT-T3L4H1 | In distribution | |
| KT-T9L13H2 | In distribution | |
| KT-T3L12H2 | In distribution | |
| KT-T4L17H2 | In distribution | |
| KT-T6L9H2 | In distribution | |
| KT-T4L4H1 | In distribution | |
| KT-T6L5H1 | In distribution | |
| KT-T2L1H1 | In distribution | |
| KT-T4L5H1 | In distribution | |
| KT-T2L12H2 | 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 |
| 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 |
| Invisx™ | Medtronic PS Medical | 12 |
Showing 12 of 32. All products under Plate, Cranioplasty, Preformed, Non-Alterable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082175 | 2008-08-13 |
| K070901 | 2007-06-15 |
| K062819 | 2006-12-04 |
| K020088 | 2002-02-08 |
| K013050 | 2001-12-10 |
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.