The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Xfix Dfs System.
| Device ID | K023399 |
| 510k Number | K023399 |
| 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 | Frederic Testa |
| Correspondent | Frederic Testa 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 | 2002-10-09 |
| Decision Date | 2002-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888480094012 | K023399 | 000 |
| 00887868105258 | K023399 | 000 |
| 00887868105241 | K023399 | 000 |
| 00887868105234 | K023399 | 000 |
| 00887868105227 | K023399 | 000 |
| 00887868105210 | K023399 | 000 |
| 00887868105203 | K023399 | 000 |
| 00887868105180 | K023399 | 000 |
| 00887868105173 | K023399 | 000 |
| 00887868105098 | K023399 | 000 |
| 00887868105081 | K023399 | 000 |
| 00887868105074 | K023399 | 000 |
| 00887868105050 | K023399 | 000 |
| 00887868105036 | K023399 | 000 |
| 00887868105265 | K023399 | 000 |
| 00887868105272 | K023399 | 000 |
| 00887868105289 | K023399 | 000 |
| 00888480093961 | K023399 | 000 |
| 00888480093879 | K023399 | 000 |
| 00888480093640 | K023399 | 000 |
| 00888480093619 | K023399 | 000 |
| 00888480093572 | K023399 | 000 |
| 00888480093558 | K023399 | 000 |
| 00888480093534 | K023399 | 000 |
| 00888480093275 | K023399 | 000 |
| 00887868105357 | K023399 | 000 |
| 00887868105340 | K023399 | 000 |
| 00887868105333 | K023399 | 000 |
| 00887868105326 | K023399 | 000 |
| 00887868105319 | K023399 | 000 |
| 00887868104558 | K023399 | 000 |