The following data is part of a premarket notification filed by Aurora Spine with the FDA for Interbody Cage System.
| Device ID | K133967 |
| 510k Number | K133967 |
| Device Name: | INTERBODY CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | AURORA SPINE 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton AURORA SPINE 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-24 |
| Decision Date | 2014-01-31 |
| Summary: | summary |