The following data is part of a premarket notification filed by Nanovis, Llc with the FDA for Nanovis Intervertebral Body Fusion System.
| Device ID | K110442 |
| 510k Number | K110442 |
| Device Name: | NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | NANOVIS, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas, Phd |
| Correspondent | Kevin A Thomas, Phd NANOVIS, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-16 |
| Decision Date | 2011-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814216024688 | K110442 | 000 |
| 00814216024527 | K110442 | 000 |
| 00814216024510 | K110442 | 000 |
| 00814216024503 | K110442 | 000 |
| 00814216024497 | K110442 | 000 |
| 00814216024480 | K110442 | 000 |
| 00814216024473 | K110442 | 000 |
| 00814216024466 | K110442 | 000 |
| 00814216024459 | K110442 | 000 |
| 00814216024435 | K110442 | 000 |
| 00814216024428 | K110442 | 000 |
| 00814216024176 | K110442 | 000 |
| 00814216024220 | K110442 | 000 |
| 00814216024213 | K110442 | 000 |
| 00814216024206 | K110442 | 000 |
| 00814216024190 | K110442 | 000 |
| 00814216024534 | K110442 | 000 |
| 00814216024541 | K110442 | 000 |
| 00814216021304 | K110442 | 000 |
| 00814216021298 | K110442 | 000 |
| 00814216021281 | K110442 | 000 |
| 00814216021274 | K110442 | 000 |
| 00814216024169 | K110442 | 000 |
| 00814216024152 | K110442 | 000 |
| 00814216023698 | K110442 | 000 |
| 00814216023681 | K110442 | 000 |
| 00814216023674 | K110442 | 000 |
| 00814216023667 | K110442 | 000 |
| 00814216023650 | K110442 | 000 |
| 00814216024589 | K110442 | 000 |
| 00814216024572 | K110442 | 000 |
| 00814216024565 | K110442 | 000 |
| 00814216024558 | K110442 | 000 |
| 00814216024183 | K110442 | 000 |