Bioplate®
Zip® Implant - 12 mm (STERILE) [6 PK]
3manufacturers in China registered for this device type
13catalogue 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 |
| 510(k) | K070901 |
| Record published | 2015-12-03 |
| Record revised | 2023-09-12 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
| Sizes | Length 11 to 60 mm |
| Distribution end date | 2022-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 81-5791[US] | Length 60 mm | In distribution |
| 81-5791-CP | Length 60 mm | In distribution |
| 81-5791 | Length 60 mm | In distribution |
| 81-3516 | Withdrawn | |
| 81-3594 | Length 12 mm | Withdrawn |
| 81-3517 | Withdrawn | |
| 81-3497 | Length 15 mm | Withdrawn |
| 81-3498 | Length 18 mm | Withdrawn |
| 81-3496 | Length 11 mm | Withdrawn |
| 81-3595[US] | Length 16 mm | Withdrawn |
| 81-3518 | Withdrawn | |
| 81-3596 | Length 20 mm | Withdrawn |
| 81-3595 | Length 16 mm | Withdrawn |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 |
| 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 |
| 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.