The following data is part of a premarket notification filed by Eisertech, Llc with the FDA for Interbody Cage.
| Device ID | K140348 |
| 510k Number | K140348 |
| Device Name: | INTERBODY CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | EISERTECH, LLC 1133 COLUMBIA STREET SUITE 107 San Diego, CA 92101 |
| Contact | Lukas Eisermann |
| Correspondent | Lukas Eisermann EISERTECH, LLC 1133 COLUMBIA STREET SUITE 107 San Diego, CA 92101 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-11 |
| Decision Date | 2015-04-23 |
| Summary: | summary |