The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Spinelink System.
| Device ID | K984027 |
| 510k Number | K984027 |
| Device Name: | EBI SPINELINK SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ELECTRO-BIOLOGY, INC. 100 INTERPACE PKWY. Parsippany, NJ 07054 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta ELECTRO-BIOLOGY, INC. 100 INTERPACE PKWY. Parsippany, NJ 07054 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-12 |
| Decision Date | 1999-01-19 |
| Summary: | summary |