The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Dynafix Vision Footplate System.
| Device ID | K052239 |
| 510k Number | K052239 |
| Device Name: | EBI DYNAFIX VISION FOOTPLATE SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Peter Allan |
| Correspondent | Peter Allan 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 | 2005-08-17 |
| Decision Date | 2005-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304529236 | K052239 | 000 |
| 00888480221395 | K052239 | 000 |
| 00888480221418 | K052239 | 000 |
| 00887868151187 | K052239 | 000 |
| 00887868151194 | K052239 | 000 |
| 00887868151200 | K052239 | 000 |
| 00887868151217 | K052239 | 000 |
| 00887868151224 | K052239 | 000 |
| 00887868151231 | K052239 | 000 |
| 00880304529212 | K052239 | 000 |
| 00880304529229 | K052239 | 000 |
| 00888480221357 | K052239 | 000 |