PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
162 catalogue numbers from KT-T6L17H2, listed by Kontour (Xi'an) Medical Technology Co., Ltd., China, under Plate, Cranioplasty, Preformed, Non-Alterable. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
162catalogue numbers in this listing
1510(k) clearance
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 | Kontour (Xi’an) Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | GXN |
| Device type | Plate, Cranioplasty, Preformed, Non-Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5330 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2022-12-08 |
| Record revised | 2026-03-30 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2025-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KT-T6L17H2 | In distribution | |
| KT-T4L3H1 | Withdrawn | |
| KT-T4L12H2 | Withdrawn | |
| KT-T3L18H1 | Withdrawn | |
| KT-T6L15H2 | Withdrawn | |
| KT-T6L10H2 | Withdrawn | |
| KT-T6L3H1 | Withdrawn | |
| KT-T3L10H2 | Withdrawn | |
| KT-T2L16H2 | Withdrawn | |
| KT-T2L14H2 | Withdrawn | |
| KT-T1L17H2 | Withdrawn | |
| KT-T6L8H2 | Withdrawn | |
| KT-T4L14H2 | Withdrawn | |
| KT-T7L4H1 | Withdrawn | |
| KT-T9L14H2 | Withdrawn | |
| KT-T8L15H2 | Withdrawn | |
| KT-T5L9H2 | Withdrawn | |
| KT-T8L14H2 | Withdrawn | |
| KT-T3L9H2 | Withdrawn | |
| KT-T9L17H2 | Withdrawn | |
| KT-T2L13H2 | Withdrawn | |
| KT-T3L7H1 | Withdrawn | |
| KT-T3L8H2 | Withdrawn | |
| KT-T2L12H2 | Withdrawn | |
| KT-T7L12H2 | Withdrawn | |
| KT-T2L6H1 | Withdrawn | |
| KT-T7L5H1 | Withdrawn | |
| KT-T4L17H2 | Withdrawn | |
| KT-T3L11H2 | Withdrawn | |
| KT-T4L9H2 | Withdrawn | |
| KT-T3L4H1 | Withdrawn | |
| KT-T1L10H2 | Withdrawn | |
| KT-T9L6H1 | Withdrawn | |
| KT-T5L7H1 | Withdrawn | |
| KT-T4L6H1 | Withdrawn | |
| KT-T1L1H1 | Withdrawn | |
| KT-T5L17H2 | Withdrawn | |
| KT-T3L5H1 | Withdrawn | |
| KT-T1L15H2 | Withdrawn | |
| KT-T4L2H1 | Withdrawn | |
| KT-T6L16H2 | Withdrawn | |
| KT-T9L5H1 | Withdrawn | |
| KT-T7L6H1 | Withdrawn | |
| KT-T8L13H2 | Withdrawn | |
| KT-T2L3H1 | Withdrawn | |
| KT-T7L2H1 | Withdrawn | |
| KT-T9L2H1 | Withdrawn | |
| KT-T6L6H1 | Withdrawn | |
| KT-T4L8H2 | Withdrawn | |
| KT-T6L14H2 | Withdrawn | |
| KT-T5L6H1 | Withdrawn | |
| KT-T5L1H1 | Withdrawn | |
| KT-T7L3H1 | Withdrawn | |
| KT-T7L10H2 | Withdrawn | |
| KT-T8L12H2 | Withdrawn | |
| KT-T6L13H2 | Withdrawn | |
| KT-T5L5H1 | Withdrawn | |
| KT-T1L2H1 | Withdrawn | |
| KT-T6L1H1 | Withdrawn | |
| KT-T2L2H1 | Withdrawn | |
| KT-T5L14H2 | Withdrawn | |
| KT-T4L10H2 | Withdrawn | |
| KT-T4L7H1 | Withdrawn | |
| KT-T1L3H1 | Withdrawn | |
| KT-T7L18H1 | Withdrawn | |
| KT-T1L11H2 | Withdrawn | |
| KT-T3L16H2 | Withdrawn | |
| KT-T3L14H2 | Withdrawn | |
| KT-T7L11H2 | Withdrawn | |
| KT-T3L17H2 | Withdrawn | |
| KT-T3L13H2 | Withdrawn | |
| KT-T3L15H2 | Withdrawn | |
| KT-T8L9H2 | Withdrawn | |
| KT-T6L2H1 | Withdrawn | |
| KT-T8L2H1 | Withdrawn | |
| KT-T7L17H2 | Withdrawn | |
| KT-T1L14H2 | Withdrawn | |
| KT-T9L7H1 | Withdrawn | |
| KT-T4L15H2 | Withdrawn | |
| KT-T5L12H2 | Withdrawn | |
| KT-T2L5H1 | Withdrawn | |
| KT-T6L5H1 | Withdrawn | |
| KT-T6L9H2 | Withdrawn | |
| KT-T3L2H1 | Withdrawn | |
| KT-T2L8H2 | Withdrawn | |
| KT-T5L3H1 | Withdrawn | |
| KT-T8L16H2 | Withdrawn | |
| KT-T1L18H1 | Withdrawn | |
| KT-T8L1H1 | Withdrawn | |
| KT-T7L16H2 | Withdrawn | |
| KT-T8L11H2 | Withdrawn | |
| KT-T1L13H2 | Withdrawn | |
| KT-T9L4H1 | Withdrawn | |
| KT-T2L17H2 | Withdrawn | |
| KT-T1L16H2 | Withdrawn | |
| KT-T1L12H2 | Withdrawn | |
| KT-T1L5H1 | Withdrawn | |
| KT-T5L8H2 | Withdrawn | |
| KT-T3L6H1 | Withdrawn | |
| KT-T2L11H2 | Withdrawn | |
| KT-T9L10H2 | Withdrawn | |
| KT-T5L15H2 | Withdrawn | |
| KT-T4L1H1 | Withdrawn | |
| KT-T8L17H2 | Withdrawn | |
| KT-T1L4H1 | Withdrawn | |
| KT-T2L7H1 | Withdrawn | |
| KT-T1L8H2 | Withdrawn | |
| KT-T7L1H1 | Withdrawn | |
| KT-T3L12H2 | Withdrawn | |
| KT-T2L4H1 | Withdrawn | |
| KT-T2L18H1 | Withdrawn | |
| KT-T5L11H2 | Withdrawn | |
| KT-T7L14H2 | Withdrawn | |
| KT-T7L15H2 | Withdrawn | |
| KT-T6L12H2 | Withdrawn | |
| KT-T8L8H2 | Withdrawn | |
| KT-T5L4H1 | Withdrawn | |
| KT-T3L1H1 | Withdrawn | |
| KT-T4L5H1 | Withdrawn | |
| KT-T3L3H1 | Withdrawn | |
| KT-T6L18H1 | Withdrawn | |
| KT-T9L3H1 | Withdrawn | |
| KT-T8L3H1 | Withdrawn | |
| KT-T2L1H1 | Withdrawn | |
| KT-T9L9H2 | Withdrawn | |
| KT-T9L8H2 | Withdrawn | |
| KT-T8L4H1 | Withdrawn | |
| KT-T4L4H1 | Withdrawn | |
| KT-T9L13H2 | Withdrawn | |
| KT-T6L4H1 | Withdrawn | |
| KT-T9L11H2 | Withdrawn | |
| KT-T8L7H1 | Withdrawn | |
| KT-T5L18H1 | Withdrawn | |
| KT-T9L1H1 | Withdrawn | |
| KT-T5L2H1 | Withdrawn | |
| KT-T2L15H2 | Withdrawn | |
| KT-T4L11H2 | Withdrawn | |
| KT-T4L13H2 | Withdrawn | |
| KT-T6L7H1 | Withdrawn | |
| KT-T5L10H2 | Withdrawn | |
| KT-T7L9H2 | Withdrawn | |
| KT-T4L18H1 | Withdrawn | |
| KT-T9L16H2 | Withdrawn | |
| KT-T2L10H2 | Withdrawn | |
| KT-T9L12H2 | Withdrawn | |
| KT-T1L9H2 | Withdrawn | |
| KT-T1L6H1 | Withdrawn | |
| KT-T2L9H2 | Withdrawn | |
| KT-T7L13H2 | Withdrawn | |
| KT-T6L11H2 | Withdrawn | |
| KT-T8L6H1 | Withdrawn | |
| KT-T8L5H1 | Withdrawn | |
| KT-T8L10H2 | Withdrawn | |
| KT-T7L7H1 | Withdrawn | |
| KT-T8L18H1 | Withdrawn | |
| KT-T4L16H2 | Withdrawn | |
| KT-T9L15H2 | Withdrawn | |
| KT-T5L13H2 | Withdrawn | |
| KT-T7L8H2 | Withdrawn | |
| KT-T1L7H1 | Withdrawn | |
| KT-T9L18H1 | Withdrawn | |
| KT-T5L16H2 | Withdrawn |
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 |
| 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 |
| Invisx™ | Medtronic PS Medical | 12 |
Showing 12 of 32. All products under Plate, Cranioplasty, Preformed, Non-Alterable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K214109 | 2022-10-28 |
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.