The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Leva (tm) Spacer System.
| Device ID | K141980 |
| 510k Number | K141980 |
| Device Name: | LEVA (TM) SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Contact | Roalda Rizkallah |
| Correspondent | Roaida Johnson SPINE WAVE, INC. THREE ENTERPRISE DR. 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 | 2014-07-21 |
| Decision Date | 2015-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642108040 | K141980 | 000 |
| 10840642100020 | K141980 | 000 |
| 10840642100037 | K141980 | 000 |
| 10840642100044 | K141980 | 000 |
| 10840642100051 | K141980 | 000 |
| 10840642100068 | K141980 | 000 |
| 10840642100075 | K141980 | 000 |
| 10840642100082 | K141980 | 000 |
| 10840642100099 | K141980 | 000 |
| 10840642100013 | K141980 | 000 |