The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Dynafix Compression Bone Screw.
| Device ID | K030706 |
| 510k Number | K030706 |
| Device Name: | EBI DYNAFIX COMPRESSION BONE SCREW |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-06 |
| Decision Date | 2003-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888480108566 | K030706 | 000 |
| 00887868082771 | K030706 | 000 |
| 00887868082764 | K030706 | 000 |
| 00887868082757 | K030706 | 000 |
| 00887868082740 | K030706 | 000 |
| 00887868082733 | K030706 | 000 |
| 00887868082726 | K030706 | 000 |
| 00887868082719 | K030706 | 000 |
| 00887868082702 | K030706 | 000 |
| 00887868082696 | K030706 | 000 |
| 00887868082689 | K030706 | 000 |
| 00887868082672 | K030706 | 000 |
| 00887868082665 | K030706 | 000 |
| 00887868082658 | K030706 | 000 |
| 00887868082641 | K030706 | 000 |
| 00887868082634 | K030706 | 000 |
| 00887868082788 | K030706 | 000 |
| 00887868082795 | K030706 | 000 |
| 00887868083006 | K030706 | 000 |
| 00887868082993 | K030706 | 000 |
| 00887868082986 | K030706 | 000 |
| 00887868082979 | K030706 | 000 |
| 00887868082962 | K030706 | 000 |
| 00887868082955 | K030706 | 000 |
| 00887868082948 | K030706 | 000 |
| 00887868082931 | K030706 | 000 |
| 00887868082924 | K030706 | 000 |
| 00887868082917 | K030706 | 000 |
| 00887868082900 | K030706 | 000 |
| 00887868082894 | K030706 | 000 |
| 00887868082887 | K030706 | 000 |
| 00887868082870 | K030706 | 000 |
| 00887868082801 | K030706 | 000 |
| 00887868082627 | K030706 | 000 |