Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K153222
Leva Spacer System · Spine Wave, Inc. · decided 2016-04-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Leva® Spacer System | 10-7242.2 | Spine Wave, Inc. | MAX | 10840642125351 |
| Leva® Spacer System | 10-7240.1 | Spine Wave, Inc. | MAX | 10840642117356 |
| Leva® Spacer System | 10-7240.2 | Spine Wave, Inc. | MAX | 10840642125382 |
| Leva® Spacer System | 10-7131.2 | Spine Wave, Inc. | MAX | 10840642107975 |
| Leva® Spacer System | 10-7242.1 | Spine Wave, Inc. | MAX | 10840642117370 |
| Leva® Spacer System | 10-7240.3 | Spine Wave, Inc. | MAX | 10840642125399 |
| Leva® Spacer System | 10-7241.1 | Spine Wave, Inc. | MAX | 10840642117363 |
| Leva® Spacer System | 10-7241.3 | Spine Wave, Inc. | MAX | 10840642125375 |
| Leva® Spacer System | 10-7241.2 | Spine Wave, Inc. | MAX | 10840642125368 |