The following data is part of a premarket notification filed by Biomet Spine (ebi Llc) with the FDA for Polaris Spinal System.
| Device ID | K111957 |
| 510k Number | K111957 |
| Device Name: | POLARIS SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | BIOMET SPINE (EBI LLC) 100 INTERPACE PARKWAY Parsippany, NJ 07540 |
| Contact | Vivian Kelly, Rac |
| Correspondent | Vivian Kelly, Rac BIOMET SPINE (EBI LLC) 100 INTERPACE PARKWAY Parsippany, NJ 07540 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-11 |
| Decision Date | 2011-08-19 |
| Summary: | summary |