The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Modification To Ebi Xfix Dfs Optirom Elbow Fixator.
| Device ID | K020403 |
| 510k Number | K020403 |
| Device Name: | MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR |
| 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 | 2002-02-07 |
| Decision Date | 2002-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304507470 | K020403 | 000 |
| 00880304486539 | K020403 | 000 |
| 00880304486546 | K020403 | 000 |
| 00880304496408 | K020403 | 000 |
| 00880304486560 | K020403 | 000 |
| 00887868084362 | K020403 | 000 |
| 00887868084379 | K020403 | 000 |
| 00887868084447 | K020403 | 000 |
| 00887868084478 | K020403 | 000 |
| 00887868084485 | K020403 | 000 |
| 00887868084492 | K020403 | 000 |
| 00887868084508 | K020403 | 000 |
| 00887868084515 | K020403 | 000 |
| 00887868084539 | K020403 | 000 |
| 00887868084546 | K020403 | 000 |
| 00880304485709 | K020403 | 000 |