The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Vertera Spine Cohere Cervical Interbody Fusion Device.
| Device ID | K173030 |
| 510k Number | K173030 |
| Device Name: | Vertera Spine Cohere Cervical Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Michelle Cheung |
| Correspondent | Michelle Cheung NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2017-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195377006813 | K173030 | 000 |
| 00195377006806 | K173030 | 000 |
| 00195377006790 | K173030 | 000 |
| 00195377006783 | K173030 | 000 |
| 00195377006769 | K173030 | 000 |
| 00195377006752 | K173030 | 000 |
| 00195377006745 | K173030 | 000 |
| 00195377006707 | K173030 | 000 |
| 00195377006691 | K173030 | 000 |