The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc with the FDA for Healix Compression Screw System.
| Device ID | K200914 |
| 510k Number | K200914 |
| Device Name: | Healix Compression Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Nvision Biomedical Technologies, Inc 4590 Lockhill Selma San Antonio, TX 78249 |
| Contact | Diana Langham |
| Correspondent | Jeffrey Brittan Watershed Ideas Foundry 1815 Aston Ave., Suite 106 Carlsbad, CA 92008 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2020-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810005665735 | K200914 | 000 |
| 00810005665728 | K200914 | 000 |
| 00810005664936 | K200914 | 000 |
| 00810005664929 | K200914 | 000 |
| 00810005662499 | K200914 | 000 |