The following data is part of a premarket notification filed by Novastep with the FDA for Lync Intramedullary Implant.
| Device ID | K143049 |
| 510k Number | K143049 |
| Device Name: | LYNC Intramedullary Implant |
| Classification | Pin, Fixation, Smooth |
| Applicant | NOVASTEP Espace Performance Alphasis - Batiment C1-C2 Saint Gregoire, FR 35769 |
| Contact | Gilles Audic |
| Correspondent | Gilles Audic NOVASTEP Espace Performance Alphasis - Batiment C1-C2 Saint Gregoire, FR 35769 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-23 |
| Decision Date | 2015-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700879500898 | K143049 | 000 |
| 03700879500430 | K143049 | 000 |
| 03700879500447 | K143049 | 000 |
| 03700879500454 | K143049 | 000 |
| 03700879500966 | K143049 | 000 |
| 03700879503578 | K143049 | 000 |
| 03700879509631 | K143049 | 000 |
| 03700879509648 | K143049 | 000 |
| 03700879509655 | K143049 | 000 |
| 03700879500515 | K143049 | 000 |
| 03700879500522 | K143049 | 000 |
| 03700879500423 | K143049 | 000 |