Confidence Spinal Cement System
CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11cc
5manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | NDN |
| Device type | Cement, Bone, Vertebroplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| 510(k) | K060300 |
| Record published | 2015-09-24 |
| Record revised | 2026-03-24 (version 4) |
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: Keep away from sunlight; Special storage condition: Flammable; Storage environment temperature 5 to 25 °C; Handling environment temperature 5 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 283905000 | In distribution | |
| 283910000 | In distribution | |
| 283913000 | In distribution |
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
Recalls Naming This Product
8 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 |
|---|---|---|---|---|---|---|---|
| Depuy Spine, Inc. | 510(k) number | 2017-12-15 | Class II | Nonconforming Material/Component | Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray. | 1972 | 2020-04-13 |
| Depuy Spine, Inc. | 510(k) number | 2013-04-17 | Class II | Process control | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. | 3896 units (Overall quantity distributed appears greater tha | 2014-08-13 |
| Depuy Spine, Inc. | 510(k) number | 2013-04-17 | Class II | Process control | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. | 3896 units (Overall quantity distributed appears greater tha | 2014-08-13 |
| Depuy Spine, Inc. | 510(k) number | 2013-04-17 | Class II | Process control | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. | 3896 units (Overall quantity distributed appears greater tha | 2014-08-13 |
| Depuy Spine, Inc. | 510(k) number | 2013-01-15 | Class II | Process control | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 1023 | 2014-06-30 |
| Depuy Spine, Inc. | 510(k) number | 2013-01-15 | Class II | Process control | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 549 | 2014-06-30 |
| Depuy Spine, Inc. | 510(k) number | 2013-01-15 | Class II | Process control | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 7773 | 2014-06-30 |
| Depuy Spine, Inc. | 510(k) number | 2013-01-15 | Class II | Process control | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 6668 | 2014-06-30 |
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.