The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Aray Spinal System.
| Device ID | K062685 |
| 510k Number | K062685 |
| Device Name: | EBI ARAY SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Debra Bing |
| Correspondent | Debra Bing 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 | 2006-09-08 |
| Decision Date | 2006-10-06 |
| Summary: | summary |