The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Xfix Dfs Rail System.
| Device ID | K000083 |
| 510k Number | K000083 |
| Device Name: | EBI XFIX DFS RAIL 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 | 2000-01-12 |
| Decision Date | 2000-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304496835 | K000083 | 000 |
| 00887868084126 | K000083 | 000 |
| 00887868083983 | K000083 | 000 |
| 00887868083907 | K000083 | 000 |
| 00887868083860 | K000083 | 000 |
| 00887868083853 | K000083 | 000 |
| 00887868083846 | K000083 | 000 |
| 00887868083839 | K000083 | 000 |
| 00887868083808 | K000083 | 000 |
| 00887868083792 | K000083 | 000 |
| 00887868083785 | K000083 | 000 |
| 00887868083778 | K000083 | 000 |
| 00887868084133 | K000083 | 000 |
| 00887868357787 | K000083 | 000 |
| 00887868357800 | K000083 | 000 |
| 00887868358111 | K000083 | 000 |
| 00887868358104 | K000083 | 000 |
| 00887868357985 | K000083 | 000 |
| 00887868357916 | K000083 | 000 |
| 00887868357886 | K000083 | 000 |
| 00887868357879 | K000083 | 000 |
| 00887868357862 | K000083 | 000 |
| 00887868357855 | K000083 | 000 |
| 00887868357831 | K000083 | 000 |
| 00887868357824 | K000083 | 000 |
| 00887868357817 | K000083 | 000 |
| 00887868083754 | K000083 | 000 |