The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Anterior Cervical Plate System.
| Device ID | K001794 |
| 510k Number | K001794 |
| Device Name: | EBI ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-14 |
| Decision Date | 2000-07-12 |