The following data is part of a premarket notification filed by Novastep with the FDA for Nexis Osteosynthesis Snap-off Screws.
| Device ID | K143146 |
| 510k Number | K143146 |
| Device Name: | Nexis Osteosynthesis Snap-off Screws |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700879500577 | K143146 | 000 |
| 03700879500379 | K143146 | 000 |
| 03700879500362 | K143146 | 000 |
| 03700879500355 | K143146 | 000 |
| 03700879500348 | K143146 | 000 |
| 03700879500331 | K143146 | 000 |
| 03700879500324 | K143146 | 000 |