The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Omega21 Spinal Fixation System.
| Device ID | K031354 |
| 510k Number | K031354 |
| Device Name: | EBI OMEGA21 SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Frederic Testa |
| Correspondent | Frederic Testa EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-29 |
| Decision Date | 2003-08-06 |
| Summary: | summary |