Cortoss
Bone Augmentation Material
5manufacturers in China registered for this device type
5catalogue numbers in this listing
7510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Ningbo Hicren Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 5 |
| Jieno Youcheng Medical Technology (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Dragon Crown Medical Co., Ltd. | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | NDN |
| Device type | Cement, Bone, Vertebroplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K080108 |
| Record published | 2015-09-24 |
| Record revised | 2023-10-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do Not Freeze; Storage environment temperature 2 to 8 °C |
| Distribution end date | 2024-08-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2110-0008 | Withdrawn | ||
| 2101-0005 | Total Volume: 5.0 Cubic Centimeter | Withdrawn | |
| 2101-0010 | Total Volume: 10.0 Cubic Centimeter | Withdrawn | |
| 2110-0031 | 3 | Withdrawn | |
| 2110-0039 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zavation | Zavation | 284 |
| CD Horizon® Fenestrated Screw Set | Medtronic Sofamor Danek, Inc. | 88 |
| StabiliT® | Merit Medical Systems, Inc. | 42 |
| Medinaut Plus Kyphoplasty System | Imedicom Co., Ltd. | 41 |
| iVAS | Stryker GmbH | 35 |
| V-Strut Vertebral Implant | Hyprevention | 28 |
| Tracker Plus Kyphoplasty System | GS Medical Co., Ltd. | 25 |
| StabiliT MX Fracture Kit | Dfine, Inc. | 12 |
| Osseoflex® | Merit Medical Systems, Inc. | 8 |
| Synth™ BES | Imedicom Co., Ltd. | 8 |
| Tracker | GS Medical Co., Ltd. | 6 |
| AVAflex | Stryker GmbH | 6 |
Showing 12 of 210. All products under Cement, Bone, Vertebroplasty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202393 | 2020-10-20 |
| K150582 | 2015-06-12 |
| K123942 | 2013-04-03 |
| K113154 | 2012-01-24 |
| K103807 | 2011-06-28 |
| K091606 | 2009-10-23 |
| K072118 | 2007-12-07 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Stryker Spine | 510(k) number | 2021-05-18 | Class II | Storage | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. | 559 total | 2022-04-15 |
| Stryker Spine | 510(k) number | 2021-05-18 | Class II | Storage | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. | 559 total | 2022-04-15 |
| Stryker Spine | 510(k) number | 2020-04-01 | Class II | Storage | Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism. | 115 | 2020-08-27 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 51 | 2019-04-16 |
| 2016-06-14 | Class II | Process control | The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for delay in surgery if additional cement needs to be prepared for t | 4,841 boxes (9,682 units) | 2017-03-27 |
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.