The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for 5.5 Helical Flange Spinal System, Polaris Components.
| Device ID | K090203 |
| 510k Number | K090203 |
| Device Name: | 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-27 |
| Decision Date | 2009-07-30 |
| Summary: | summary |