Level ONE Thoracic, Sterile
Sternal Talon, Single Foot, Extra Small, TI-6AL-4V
3manufacturers in China registered for this device type
14catalogue 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 | KLS-Martin L.P., United States |
|---|---|
| FDA product code | GXN |
| Device type | Plate, Cranioplasty, Preformed, Non-Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5330 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-03-23 |
| Record revised | 2019-08-21 (version 5) |
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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24-010-14-71 | 14 MM | In distribution |
| 24-010-20-71 | 20 MM | In distribution |
| 24-009-14-71 | 14 MM | In distribution |
| 24-020-11-71 | 11 MM | In distribution |
| 24-008-14-71 | 14 MM | In distribution |
| 24-011-20-71 | 20 MM | In distribution |
| 24-010-11-71 | 11 MM | In distribution |
| 24-019-17-71 | 17 MM | In distribution |
| 24-008-11-71 | 11 MM | In distribution |
| 24-019-11-71 | 11 MM | In distribution |
| 24-011-14-71 | 14 MM | In distribution |
| 24-012-17-71 | 17 MM | In distribution |
| 24-011-11-71 | 11 MM | In distribution |
| 24-009-11-71 | 11 MM | 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 |
| 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 |
|---|---|
| K252573 | 2025-11-10 |
| K151382 | 2015-11-09 |
| K072707 | 2007-12-19 |
| K062857 | 2006-11-22 |
| K062570 | 2006-10-31 |
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.