The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Modification To Omega 21 System.
| Device ID | K001357 |
| 510k Number | K001357 |
| Device Name: | MODIFICATION TO OMEGA 21 SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Jonas Wilf |
| Correspondent | Jonas Wilf EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-28 |
| Decision Date | 2000-07-20 |