The following data is part of a premarket notification filed by Neo Medical S.a. with the FDA for Neo Cage System.
| Device ID | K191796 |
| 510k Number | K191796 |
| Device Name: | Neo Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Neo Medical S.A. Route De Lausanne 157A Villette (lavaux), CH 1096 |
| Contact | Jonas Larsson |
| Correspondent | Charles Cathlin Confinis Corporation 15807 Glacier Ct North Potomac, MD 20878 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640177822680 | K191796 | 000 |
| 07640177822512 | K191796 | 000 |
| 07640177822505 | K191796 | 000 |
| 07640177822499 | K191796 | 000 |
| 07640177822482 | K191796 | 000 |
| 07640177822475 | K191796 | 000 |
| 07640177822468 | K191796 | 000 |
| 07640177822451 | K191796 | 000 |
| 07640177822444 | K191796 | 000 |
| 07640177822437 | K191796 | 000 |
| 07640177822420 | K191796 | 000 |
| 07640177822413 | K191796 | 000 |
| 07640177822406 | K191796 | 000 |
| 07640177822390 | K191796 | 000 |
| 07640177822383 | K191796 | 000 |
| 07640177822529 | K191796 | 000 |
| 07640177822536 | K191796 | 000 |
| 07640177822673 | K191796 | 000 |
| 07640177822666 | K191796 | 000 |
| 07640177822659 | K191796 | 000 |
| 07640177822642 | K191796 | 000 |
| 07640177822635 | K191796 | 000 |
| 07640177822628 | K191796 | 000 |
| 07640177822611 | K191796 | 000 |
| 07640177822604 | K191796 | 000 |
| 07640177822598 | K191796 | 000 |
| 07640177822581 | K191796 | 000 |
| 07640177822574 | K191796 | 000 |
| 07640177822567 | K191796 | 000 |
| 07640177822550 | K191796 | 000 |
| 07640177822543 | K191796 | 000 |
| 07640177822376 | K191796 | 000 |