The following data is part of a premarket notification filed by Biomet Spine with the FDA for Lineum Oct Spine System.
| Device ID | K151224 |
| 510k Number | K151224 |
| Device Name: | Lineum OCT Spine System |
| Classification | Posterior Cervical Screw System |
| Applicant | BIOMET SPINE 310 INTERLOCKEN PARKWAY, SUITE 120 Broomfield, CO 80021 |
| Contact | Spencer Kimber |
| Correspondent | Spencer Kimber BIOMET SPINE 310 INTERLOCKEN PARKWAY, SUITE 120 Broomfield, CO 80021 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-07 |
| Decision Date | 2015-06-30 |
| Summary: | summary |