The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Xfix Dfs Wristfix System.
| Device ID | K993649 |
| 510k Number | K993649 |
| Device Name: | EBI XFIX DFS WRISTFIX 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 | 1999-10-29 |
| Decision Date | 1999-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868357503 | K993649 | 000 |
| 00888480105701 | K993649 | 000 |
| 00887868082450 | K993649 | 000 |
| 00887868082443 | K993649 | 000 |
| 00887868082399 | K993649 | 000 |
| 00887868082382 | K993649 | 000 |
| 00887868082191 | K993649 | 000 |
| 00887868082184 | K993649 | 000 |