The following data is part of a premarket notification filed by Ebi, Llc with the FDA for Nextgen Altius Oct System.
| Device ID | K140734 |
| 510k Number | K140734 |
| Device Name: | NEXTGEN ALTIUS OCT SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | EBI, LLC 399 Jefferson Rd Parsippany, NJ 07054 |
| Contact | Ted Kuhn |
| Correspondent | Ted Kuhn EBI, LLC 399 Jefferson Rd Parsippany, NJ 07054 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-24 |
| Decision Date | 2014-12-15 |
| Summary: | summary |