Kinex Bioactive
510(k) K130392
Kinex Bioactive is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K130392 on 15 Aug 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130392 | Date15 Aug 2013 | StatusActive |
Official records
- FDA 510(k) database K130392
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQV
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K130392
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| KINEX 8115.0005S | 8115.0005S | 00889095206111 | Height 4 mm; Length 50 mm; Total Volume 5 mL; Width 25 mm | On the market |
| KINEX 8115.0010S | 8115.0010S | 00889095206128 | Total Volume 10 mL; Width 25 mm; Height 8 mm; Length 50 mm | On the market |
| KINEX 8115.0110S | 8115.0110S | 00889095206135 | Width 25 mm; Length 100 mm; Total Volume 10 mL; Height 4 mm | On the market |
| KINEX 8115.0120S | 8115.0120S | 00889095206142 | Height 8 mm; Total Volume 20 mL; Width 25 mm; Length 100 mm | On the market |
| KINEX 8115.0202S | 8115.0202S | 00889095206159 | Total Volume 2 mL | On the market |
| KINEX 8115.0205S | 8115.0205S | 00889095206166 | Total Volume 5 mL | On the market |
| KINEX 8115.0210S | 8115.0210S | 00889095206173 | Total Volume 10 mL | On the market |
| KINEX 8115.0302S | 8115.0302S | 00889095206180 | Total Volume 2 mL | On the market |
| KINEX 8115.0305S | 8115.0305S | 00889095206197 | Total Volume 5 mL | On the market |
| KINEX 8115.0310S | 8115.0310S | 00889095206203 | Total Volume 10 mL | On the market |
| KINEX 8115.5202S | 8115.5202S | 00889095206258 | Total Volume 2 mL | On the market |
| KINEX 8115.5205S | 8115.5205S | 00889095206265 | Total Volume 5 mL | On the market |
| KINEX 8115.5210S | 8115.5210S | 00889095206272 | Total Volume 10 mL | On the market |
| KINEX 8115.5302S | 8115.5302S | 00889095206289 | Total Volume 2 mL | On the market |
| KINEX 8115.5305S | 8115.5305S | 00889095206296 | Total Volume 5 mL | On the market |
| KINEX 8115.5310S | 8115.5310S | 00889095206302 | Total Volume 10 mL | On the market |
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