The following data is part of a premarket notification filed by Biomet Spine (aka Ebi, Llc) with the FDA for Polaris Spinal System.
| Device ID | K131615 |
| 510k Number | K131615 |
| Device Name: | POLARIS SPINAL SYSTEM |
| Classification | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Applicant | BIOMET SPINE (AKA EBI, LLC) 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly BIOMET SPINE (AKA EBI, LLC) 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | OSH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2013-09-04 |
| Summary: | summary |