The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Xfix Dfs System.
| Device ID | K000319 |
| 510k Number | K000319 |
| 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 | Jonas Wilf |
| Correspondent | Jonas Wilf 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 | 2000-02-02 |
| Decision Date | 2000-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888480153221 | K000319 | 000 |
| 00887868081507 | K000319 | 000 |
| 00887868081491 | K000319 | 000 |
| 00887868081484 | K000319 | 000 |
| 00887868081477 | K000319 | 000 |
| 00887868081460 | K000319 | 000 |
| 00887868081453 | K000319 | 000 |
| 00887868081446 | K000319 | 000 |
| 00887868081422 | K000319 | 000 |
| 00887868081514 | K000319 | 000 |
| 00887868081538 | K000319 | 000 |
| 00888480153214 | K000319 | 000 |
| 00888480153207 | K000319 | 000 |
| 00888480104421 | K000319 | 000 |
| 00888480104049 | K000319 | 000 |
| 00888480103967 | K000319 | 000 |
| 00887868081576 | K000319 | 000 |
| 00887868081569 | K000319 | 000 |
| 00887868081552 | K000319 | 000 |
| 00887868081583 | K000319 | 000 |