iVAS
11 gauge 15mm iVAS Elite Single Balloon Kit
5manufacturers in China registered for this device type
35catalogue 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 |
| Record published | 2019-01-14 |
| Record revised | 2021-11-18 (version 9) |
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 | Storage environment humidity 10 to 60 % RH; Storage environment temperature 12 to 25 °C |
| Packaging | Pack of 3 |
| Sizes | Needle gauge 8 to 13 G; length 10 to 20 mm |
| Distribution end date | 2021-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 808820800 | Balloon Length: 20.0 Millimeter | In distribution |
| 1021320000 | Needle Gauge 13.0 G | In distribution |
| 1021315000 | Needle Gauge 13.0 G | In distribution |
| 808815000 | Balloon Length: 15.0 Millimeter | In distribution |
| 808115000 | Needle Gauge 11.0 G | In distribution |
| 808020500 | Balloon Length: 20.0 Millimeter | In distribution |
| 1021310000 | Needle Gauge 13.0 G | In distribution |
| 808020000 | Needle Gauge 10.0 G | In distribution |
| 808015500 | Needle Gauge 10.0 G | In distribution |
| 808010500 | Balloon Length: 10.0 Millimeter | In distribution |
| 808015800 | Balloon Length: 15.0 Millimeter | In distribution |
| 808010000 | Balloon Length: 10.0 Millimeter | In distribution |
| 808115500 | Balloon Length: 15.0 Millimeter | In distribution |
| 808110500 | Balloon Length: 10.0 Millimeter | In distribution |
| 808020800 | In distribution | |
| 808010800 | Needle Gauge 10.0 G | In distribution |
| 808815800 | Balloon Length: 15.0 Millimeter | In distribution |
| 808115800 | Needle Gauge 11.0 G | In distribution |
| 0705810000 | Needle Gauge 8.0 G | In distribution |
| 808820000 | Balloon Length: 20.0 Millimeter | In distribution |
| 808015000 | Balloon Length: 15.0 Millimeter | In distribution |
| 808110000 | In distribution | |
| 808110800 | Needle Gauge 11.0 G | In distribution |
| 0705820000 | Needle Gauge 8.0 G | Withdrawn |
| 0705110500 | Length 10.0 mm | Withdrawn |
| 0705310000 | Needle Gauge 11.0 G | Withdrawn |
| 0705120000 | Length 20.0 mm | Withdrawn |
| 0705315000 | Distal Length: 15.0 Millimeter | Withdrawn |
| 0705310500 | Needle Gauge 11.0 G | Withdrawn |
| 0705120500 | Needle Gauge 10.0 G | Withdrawn |
| 0705110000 | Length 10.0 mm | Withdrawn |
| 0705315500 | Length 15.0 mm | Withdrawn |
| 0705115000 | Length 15.0 mm | Withdrawn |
| 0705815000 | Length 15.0 mm | Withdrawn |
| 0705115500 | Length 15.0 mm | 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 |
| 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 |
| Spider Kolibri | Sintea Plustek | 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
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.