The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi P148 Spinal Fixation System.
| Device ID | K031423 |
| 510k Number | K031423 |
| Device Name: | EBI P148 SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Jon Caparetta |
| Correspondent | Jon Caparetta EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-06 |
| Decision Date | 2003-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304225497 | K031423 | 000 |