The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Xfix Rail System.
| Device ID | K021031 |
| 510k Number | K021031 |
| Device Name: | EBI XFIX RAIL SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Michael T Taggart |
| Correspondent | Michael T Taggart EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2002-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304509177 | K021031 | 000 |
| 00887868083693 | K021031 | 000 |
| 00887868083716 | K021031 | 000 |
| 00887868083730 | K021031 | 000 |
| 00887868084041 | K021031 | 000 |
| 00887868084072 | K021031 | 000 |
| 00887868084096 | K021031 | 000 |
| 00887868357701 | K021031 | 000 |
| 00887868357725 | K021031 | 000 |
| 00887868357749 | K021031 | 000 |
| 00887868357763 | K021031 | 000 |
| 00887868358036 | K021031 | 000 |
| 00887868358043 | K021031 | 000 |
| 00887868358067 | K021031 | 000 |
| 00887868358074 | K021031 | 000 |
| 00887868083679 | K021031 | 000 |