The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Spinelink System.
| Device ID | K964533 |
| 510k Number | K964533 |
| Device Name: | EBI SPINELINK SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Contact | Sharon A Starowicz |
| Correspondent | Sharon A Starowicz ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-12 |
| Decision Date | 1997-04-09 |
| Summary: | summary |