RapidSorb
Rapidsorb IPS Delivery Device Replacement CAP-Sterile
3manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Quanzhou Apex Hygiene Products Co., Ltd. | Jinjiang | Fujian | Manufacturer | 8 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HBW |
| Device type | Fastener, Plate, Cranioplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5360 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K141385 |
| Record published | 2016-10-07 |
| Record revised | 2024-09-19 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from heat and radio- active sources; Handling environment temperature -55 to 40 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 805.505.01S | In distribution | |
| 530.555.01S | In distribution | |
| 530.551 | In distribution | |
| 530.554 | In distribution | |
| 805.510.01S | In distribution | |
| 805.520.01S | In distribution | |
| 530.553.01S | In distribution | |
| 805.550.01S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 1.5MM System | Biomet Microfixation | 87 |
| Neuro Plating System | Osteonic Co., Ltd. | 55 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 40 |
| “2.0MM” System | Biomet Microfixation | 26 |
| Resorb XG, Sterile | KLS-Martin L.P. | 18 |
| Leforte Neuro System Bone Plate | Jeil Medical Corporation | 15 |
| CMF System | Biomet Microfixation | 14 |
| Fastener, Plate, Cranioplasty | Biomet Microfixation | 14 |
| AXS | Stryker Leibinger Gmbh & Co. KG | 14 |
| Raas Cranial Plating System | Alliance Partners, LLC | 12 |
| Thinflap System | Biomet Microfixation | 12 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 11 |
Showing 12 of 45. All products under Fastener, Plate, Cranioplasty
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2024-01-24 | Class II | Process control | Products not sterilized, sterility cannot be confirmed | 10 units |
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.