The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Leva Anterior Expandable Spacer System.
| Device ID | K163246 |
| 510k Number | K163246 |
| Device Name: | Leva Anterior Expandable Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINE WAVE, INC. 3 ENTERPRISE DRIVE, SUITE 210 Shelton, CT 06484 |
| Contact | Amy Noccioli |
| Correspondent | Amy Noccioli SPINE WAVE, INC. 3 ENTERPRISE DRIVE, SUITE 210 Shelton, CT 06484 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-18 |
| Decision Date | 2017-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642111293 | K163246 | 000 |
| 10840642109245 | K163246 | 000 |
| 10840642109238 | K163246 | 000 |
| 10840642109221 | K163246 | 000 |
| 10840642109214 | K163246 | 000 |
| 10840642109207 | K163246 | 000 |
| 10840642109191 | K163246 | 000 |
| 10840642109184 | K163246 | 000 |
| 10840642109177 | K163246 | 000 |
| 10840642109160 | K163246 | 000 |
| 10840642109153 | K163246 | 000 |
| 10840642109146 | K163246 | 000 |
| 10840642109139 | K163246 | 000 |
| 10840642109252 | K163246 | 000 |
| 10840642109269 | K163246 | 000 |
| 10840642109276 | K163246 | 000 |
| 10840642111286 | K163246 | 000 |
| 10840642111279 | K163246 | 000 |
| 10840642111262 | K163246 | 000 |
| 10840642111255 | K163246 | 000 |
| 10840642109351 | K163246 | 000 |
| 10840642109344 | K163246 | 000 |
| 10840642109337 | K163246 | 000 |
| 10840642109320 | K163246 | 000 |
| 10840642109313 | K163246 | 000 |
| 10840642109306 | K163246 | 000 |
| 10840642109290 | K163246 | 000 |
| 10840642109283 | K163246 | 000 |
| 10840642109122 | K163246 | 000 |