The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Leva(tm) Spacer System.
| Device ID | K150285 |
| 510k Number | K150285 |
| Device Name: | Leva(TM) Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINE WAVE, INC. 3 ENTERPRISE DRIVE SUITE 210 Shelton, CT 06484 |
| Contact | Roaida Johnson |
| Correspondent | Roaida Johnson 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 | 2015-02-05 |
| Decision Date | 2015-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642100358 | K150285 | 000 |
| 10840642100341 | K150285 | 000 |
| 10840642100334 | K150285 | 000 |
| 10840642100327 | K150285 | 000 |
| 10840642100310 | K150285 | 000 |