The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Xfix Vision Fixation System.
| Device ID | K993886 |
| 510k Number | K993886 |
| Device Name: | EBI XFIX VISION FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta 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 | 1999-11-16 |
| Decision Date | 1999-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304509658 | K993886 | 000 |
| 00888480188483 | K993886 | 000 |
| 00888480188407 | K993886 | 000 |
| 00888480188391 | K993886 | 000 |
| 00888480188360 | K993886 | 000 |
| 00888480188353 | K993886 | 000 |
| 00888480188322 | K993886 | 000 |
| 00888480188315 | K993886 | 000 |
| 00888480188292 | K993886 | 000 |
| 00888480188063 | K993886 | 000 |
| 00888480188018 | K993886 | 000 |
| 00887868090233 | K993886 | 000 |
| 00887868090226 | K993886 | 000 |
| 00880304485365 | K993886 | 000 |
| 00880304485709 | K993886 | 000 |
| 00880304486478 | K993886 | 000 |
| 00880304501294 | K993886 | 000 |
| 00880304501270 | K993886 | 000 |
| 00880304501140 | K993886 | 000 |
| 00880304496408 | K993886 | 000 |
| 00880304495210 | K993886 | 000 |
| 00880304492684 | K993886 | 000 |
| 00880304491120 | K993886 | 000 |
| 00880304488281 | K993886 | 000 |
| 00880304486560 | K993886 | 000 |
| 00880304486546 | K993886 | 000 |
| 00880304486539 | K993886 | 000 |
| 00880304486515 | K993886 | 000 |
| 00887868090219 | K993886 | 000 |