The following data is part of a premarket notification filed by Ebi, Llc with the FDA for Polaris Spinal System -translation Screw.
| Device ID | K140123 |
| 510k Number | K140123 |
| Device Name: | POLARIS SPINAL SYSTEM -TRANSLATION SCREW |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | EBI, LLC 399 Jefferson Rd Parsippany, NJ 07054 |
| Contact | Mike Medina |
| Correspondent | Mike Medina EBI, LLC 399 Jefferson Rd Parsippany, NJ 07054 |
| 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 | 2014-01-16 |
| Decision Date | 2014-04-24 |
| Summary: | summary |