The following data is part of a premarket notification filed by Biomet Spine with the FDA for Polaris Spinal System.
| Device ID | K151974 |
| 510k Number | K151974 |
| Device Name: | Polaris Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | BIOMET SPINE 310 INTERLOCKEN PARKWAY, SUITE 120 Broomfield, CO 80021 |
| Contact | Alexandra Beck |
| Correspondent | Alexandra Beck BIOMET SPINE 310 INTERLOCKEN PARKWAY, SUITE 120 Broomfield, CO 80021 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-16 |
| Decision Date | 2015-11-13 |
| Summary: | summary |