The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Leva Spacer System.
| Device ID | K151581 |
| 510k Number | K151581 |
| Device Name: | Leva Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINE WAVE, INC. 3 ENTERPRISE DRIVE, SUITE 210 Shelton, CT 06484 |
| Contact | Gail Yaeker-daunis |
| Correspondent | Gail Yaeker-daunis SPINE WAVE, INC. 3 ENTERPRISE DRIVE, SUITE 210 Shelton, CT 06484 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-11 |
| Decision Date | 2015-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642100495 | K151581 | 000 |
| 10840642100389 | K151581 | 000 |
| 10840642100396 | K151581 | 000 |
| 10840642100402 | K151581 | 000 |
| 10840642100419 | K151581 | 000 |
| 10840642100426 | K151581 | 000 |
| 10840642100433 | K151581 | 000 |
| 10840642100440 | K151581 | 000 |
| 10840642100457 | K151581 | 000 |
| 10840642100464 | K151581 | 000 |
| 10840642100471 | K151581 | 000 |
| 10840642100488 | K151581 | 000 |
| 10840642100372 | K151581 | 000 |