The following data is part of a premarket notification filed by Biomet Spine (aka Ebi, Llc) with the FDA for Nextgen Altius Oct System.
| Device ID | K122378 |
| 510k Number | K122378 |
| Device Name: | NEXTGEN ALTIUS OCT SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | BIOMET SPINE (AKA EBI, LLC) 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly BIOMET SPINE (AKA EBI, LLC) 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2012-09-20 |
| Summary: | summary |