The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Modification To Ebi Xfix Dfs Rail System.
| Device ID | K010437 |
| 510k Number | K010437 |
| Device Name: | MODIFICATION TO 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 | Patricia Flood |
| Correspondent | Patricia Flood 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 | 2001-02-13 |
| Decision Date | 2001-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868357633 | K010437 | 000 |
| 00887868082597 | K010437 | 000 |
| 00887868082573 | K010437 | 000 |
| 00887868082566 | K010437 | 000 |
| 00887868082559 | K010437 | 000 |
| 00887868082542 | K010437 | 000 |
| 00887868082535 | K010437 | 000 |
| 00887868082528 | K010437 | 000 |
| 00887868082511 | K010437 | 000 |
| 00887868082504 | K010437 | 000 |
| 00887868082498 | K010437 | 000 |
| 00887868082481 | K010437 | 000 |
| 00887868082610 | K010437 | 000 |
| 00887868093067 | K010437 | 000 |
| 00887868357626 | K010437 | 000 |
| 00887868357619 | K010437 | 000 |
| 00887868357602 | K010437 | 000 |
| 00887868357596 | K010437 | 000 |
| 00887868357589 | K010437 | 000 |
| 00887868357572 | K010437 | 000 |
| 00887868357565 | K010437 | 000 |
| 00887868357558 | K010437 | 000 |
| 00887868357541 | K010437 | 000 |
| 00887868357534 | K010437 | 000 |
| 00887868357527 | K010437 | 000 |
| 00887868081606 | K010437 | 000 |