The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Vertex Nitinol Staple System.
| Device ID | K182943 |
| 510k Number | K182943 |
| Device Name: | VERTEX Nitinol Staple System |
| Classification | Staple, Fixation, Bone |
| Applicant | Nvision Biomedical Technologies, LLC 4754 Shavano Oak, Suite 101 San Antonio, TX 78249 |
| Contact | Diana Langham |
| Correspondent | Jeffrey Brittan Watershed Ideas Foundry 1815 Aston Ave., Suite 106 Carlsbad, CA 92008 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-23 |
| Decision Date | 2019-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810005667289 | K182943 | 000 |
| 00810005661003 | K182943 | 000 |
| 00810005661010 | K182943 | 000 |
| 00810005661027 | K182943 | 000 |
| 00810005661034 | K182943 | 000 |
| 00810005661041 | K182943 | 000 |
| 00810005661058 | K182943 | 000 |
| 00810005661065 | K182943 | 000 |
| 00810005661072 | K182943 | 000 |
| 00810005661089 | K182943 | 000 |
| 00810005661096 | K182943 | 000 |
| 00810005665155 | K182943 | 000 |
| 00810005665162 | K182943 | 000 |
| 00810005667258 | K182943 | 000 |
| 00810005667265 | K182943 | 000 |
| 00810005667272 | K182943 | 000 |
| 00810005665278 | K182943 | 000 |