The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Spinelink - Ii Spinal Fixation System.
| Device ID | K012516 |
| 510k Number | K012516 |
| Device Name: | EBI SPINELINK - II SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Patricia M Flood |
| Correspondent | Patricia M Flood EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-11-27 |
| Summary: | summary |