The following data is part of a premarket notification filed by Neo Medical S.a. with the FDA for Neo Cage System Tm.
| Device ID | K181048 |
| 510k Number | K181048 |
| Device Name: | Neo Cage System TM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Neo Medical S.A. Route De Lausanne 157 A Villette, CH 1096 |
| Contact | Jonas Larsson |
| Correspondent | Jonas Larsson confinis USA Route De Lausanne 157A Villette (lavaux), CH 1096 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-19 |
| Decision Date | 2019-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640177822222 | K181048 | 000 |
| 07640177822116 | K181048 | 000 |
| 07640177822109 | K181048 | 000 |
| 07640177822093 | K181048 | 000 |
| 07640177822086 | K181048 | 000 |
| 07640177822079 | K181048 | 000 |
| 07640177822062 | K181048 | 000 |
| 07640177822055 | K181048 | 000 |
| 07640177822048 | K181048 | 000 |
| 07640177822123 | K181048 | 000 |
| 07640177822130 | K181048 | 000 |
| 07640177822215 | K181048 | 000 |
| 07640177822208 | K181048 | 000 |
| 07640177822192 | K181048 | 000 |
| 07640177822185 | K181048 | 000 |
| 07640177822178 | K181048 | 000 |
| 07640177822161 | K181048 | 000 |
| 07640177822154 | K181048 | 000 |
| 07640177822147 | K181048 | 000 |
| 07640177822031 | K181048 | 000 |