Rapidflap (TM) System
9 catalogue numbers from 75-1030-12, listed by Biomet Microfixation, United States, under Plate, Cranioplasty, Preformed, Non-Alterable. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
9catalogue numbers in this listing
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 | Biomet Microfixation, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K031034 |
| Record published | 2020-06-18 |
| Record revised | 2025-06-09 (version 8) |
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 |
| Distribution end date | 2020-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 75-1030-12 | In distribution | |
| 75-1040-12 | In distribution | |
| 75-1020 | In distribution | |
| 75-1040 | In distribution | |
| 75-1030 | In distribution | |
| 75-1020-12 | In distribution | |
| 75-1030-12 | Withdrawn | |
| 75-1020-12 | Withdrawn | |
| 75-1040-12 | Withdrawn |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 |
| Bioplate® | Bioplate, Inc. | 13 |
Showing 12 of 32. All products under Plate, Cranioplasty, Preformed, Non-Alterable
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2018-08-22 | Class II | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. | 12825 units | 2021-06-17 |
| Biomet, Inc. | 510(k) number | 2018-08-22 | Class II | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. | 11736 units | 2021-06-17 |
| Biomet, Inc. | 510(k) number | 2018-08-22 | Class II | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. | 23726 units | 2021-06-17 |
| Biomet, Inc. | 510(k) number | 2018-08-22 | Class II | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. | 11580 units | 2021-06-17 |
| Biomet, Inc. | 510(k) number | 2018-08-22 | Class II | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. | 3246 units | 2021-06-17 |
| Biomet, Inc. | 510(k) number | 2018-08-22 | Class II | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. | 6180 units | 2021-06-17 |
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.