The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Xfix Dfs System.
| Device ID | K031645 |
| 510k Number | K031645 |
| Device Name: | EBI XFIX DFS SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Art Kaufman |
| Correspondent | Art Kaufman EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-28 |
| Decision Date | 2003-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304534650 | K031645 | 000 |
| 00880304486294 | K031645 | 000 |
| 00888480190516 | K031645 | 000 |
| 00888480190509 | K031645 | 000 |
| 00888480190486 | K031645 | 000 |
| 00888480190370 | K031645 | 000 |
| 00888480190356 | K031645 | 000 |
| 00888480190325 | K031645 | 000 |