IPS
Implant, Mandible, Crib Mesh, 00074, 1.5 MM Screw, ALT, TI-6AL-4V
3manufacturers in China registered for this device type
74catalogue 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 | 2016-03-24 |
| Record revised | 2022-04-15 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2021-11-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-000-17-09-PP | In distribution | |
| 60-000-27-09-LP | In distribution | |
| 993-02-6693 | In distribution | |
| 60-000-22-09-PP | In distribution | |
| 60-000-41-09-LP | In distribution | |
| 60-000-31-09-LP | In distribution | |
| 60-000-32-09 | In distribution | |
| 60-000-26-09 | In distribution | |
| 60-000-18-09-PP | In distribution | |
| 60-000-23-09 | In distribution | |
| 60-000-87-09 | In distribution | |
| 60-000-43-09 | In distribution | |
| 60-000-36-09 | In distribution | |
| 60-000-19-09-PP | In distribution | |
| 60-000-21-09-LP | In distribution | |
| 60-000-29-09-LP | In distribution | |
| 60-000-35-09 | In distribution | |
| 60-000-89-09 | In distribution | |
| 60-000-86-09 | In distribution | |
| 60-000-17-09 | In distribution | |
| 60-000-29-09 | In distribution | |
| 60-611-11-04 | In distribution | |
| 60-000-41-09 | In distribution | |
| 60-000-27-09-PP | In distribution | |
| 60-000-37-09-LP | In distribution | |
| 60-000-22-09-LP | In distribution | |
| 60-000-38-09-LP | In distribution | |
| 60-000-16-09 | In distribution | |
| 60-000-88-09 | In distribution | |
| 60-000-30-09 | In distribution | |
| 60-000-40-09-LP | In distribution | |
| 60-000-74-09 | In distribution | |
| 60-000-39-09-LP | In distribution | |
| 60-000-19-09 | In distribution | |
| 60-000-23-09-LP | In distribution | |
| 60-000-24-09-LP | In distribution | |
| 60-000-25-09 | In distribution | |
| 60-000-32-09-LP | In distribution | |
| 60-611-01-04 | In distribution | |
| 60-001-94-09 | In distribution | |
| 60-000-34-09-LP | In distribution | |
| 60-000-24-09-PP | In distribution | |
| 60-000-35-09-LP | In distribution | |
| 60-000-74-09-PP | In distribution | |
| 60-000-19-09-LP | In distribution | |
| 60-000-42-09-PP | In distribution | |
| 60-000-43-09-LP | In distribution | |
| 60-000-74-09-LP | In distribution | |
| 60-000-39-09 | In distribution | |
| 00-889-25-89 | Withdrawn | |
| 00-889-25-90 | Withdrawn | |
| 993-03-6456 | Withdrawn | |
| 60-000-53-09 | Withdrawn | |
| 00-889-25-86 | Withdrawn | |
| 60-610-04-04 | Withdrawn | |
| 60-000-61-09 | Withdrawn | |
| 00-888-25-47 | Withdrawn | |
| 993-02-8770 | REGULAR | Withdrawn |
| 993-02-7512 | Withdrawn | |
| 60-610-03-04 | Withdrawn | |
| 00-889-25-87 | Withdrawn | |
| 00-889-25-81 | Withdrawn | |
| 60-000-59-09 | Withdrawn | |
| 993-02-6403 | Withdrawn | |
| 00-888-25-46 | Withdrawn | |
| 00-889-25-84 | Withdrawn | |
| 992-05-7731 | Withdrawn | |
| 60-610-02-04 | Withdrawn | |
| 60-620-05-04 | Withdrawn | |
| 60-610-01-04 | Withdrawn | |
| 992-03-6300 | Withdrawn | |
| 60-000-60-09 | Withdrawn | |
| 60-000-58-09 | Withdrawn | |
| 60-610-05-04 | 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 |
| PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | Kontour (Xi’an) Medical Technology Co., Ltd. | 162 |
| CranioFit | Bioplate, Inc. | 161 |
| 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 |
|---|---|
| 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.