The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Leva Spacer System.
| Device ID | K153222 |
| 510k Number | K153222 |
| 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 | Amnon Talmor 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 | 2015-11-06 |
| Decision Date | 2016-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642125399 | K153222 | 000 |
| 10840642125382 | K153222 | 000 |
| 10840642125375 | K153222 | 000 |
| 10840642125368 | K153222 | 000 |
| 10840642125351 | K153222 | 000 |
| 10840642117370 | K153222 | 000 |
| 10840642117363 | K153222 | 000 |
| 10840642117356 | K153222 | 000 |
| 10840642107975 | K153222 | 000 |