The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Dynafix Diaphyseal Correction System.
| Device ID | K021695 |
| 510k Number | K021695 |
| Device Name: | EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Patricia M Flood |
| Correspondent | Patricia M 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 | 2002-05-22 |
| Decision Date | 2002-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304533776 | K021695 | 000 |
| 00887868093050 | K021695 | 000 |
| 00888480190318 | K021695 | 000 |
| 00888480190349 | K021695 | 000 |
| 00888480190431 | K021695 | 000 |
| 00888480190448 | K021695 | 000 |
| 00888480190455 | K021695 | 000 |
| 00880304487406 | K021695 | 000 |
| 00880304489530 | K021695 | 000 |
| 00880304490734 | K021695 | 000 |
| 00880304492752 | K021695 | 000 |
| 00880304532427 | K021695 | 000 |
| 00880304533769 | K021695 | 000 |
| 00888480444374 | K021695 | 000 |