The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Spine Wave Gen Ii Expandable Interbody System.
| Device ID | K152620 |
| 510k Number | K152620 |
| Device Name: | Spine Wave Gen II Expandable Interbody 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-14 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642107876 | K152620 | 000 |
| 10840642106794 | K152620 | 000 |
| 10840642106800 | K152620 | 000 |
| 10840642106817 | K152620 | 000 |
| 10840642106824 | K152620 | 000 |
| 10840642106831 | K152620 | 000 |
| 10840642106848 | K152620 | 000 |
| 10840642106855 | K152620 | 000 |
| 10840642106862 | K152620 | 000 |
| 10840642106879 | K152620 | 000 |
| 10840642106886 | K152620 | 000 |
| 10840642106893 | K152620 | 000 |
| 10840642106909 | K152620 | 000 |
| 10840642106916 | K152620 | 000 |
| 10840642107869 | K152620 | 000 |
| 10840642106787 | K152620 | 000 |