The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Spinelink Anterior Cervical Spinal System.
| Device ID | K022419 |
| 510k Number | K022419 |
| Device Name: | EBI SPINELINK ANTERIOR CERVICAL SPINAL 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 (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-24 |
| Decision Date | 2002-08-12 |
| Summary: | summary |