The following data is part of a premarket notification filed by Nexus Spine, Llc with the FDA for Presson Pro Spinal Fixation System.
| Device ID | K160820 |
| 510k Number | K160820 |
| Device Name: | PressON Pro Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Nexus Spine, LLC 2825 E Cottonwood Parkway, Suite 330 Salt Lake City, UT 84121 |
| Contact | Jared Crocker |
| Correspondent | Jared Crocker Nexus Spine, LLC 2825 E Cottonwood Parkway, Suite 330 Salt Lake City, UT 84121 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-24 |
| Decision Date | 2016-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B678520215S0 | K160820 | 000 |
| B678520230S0 | K160820 | 000 |
| B678520231S0 | K160820 | 000 |
| B678520232S0 | K160820 | 000 |
| B678520233S0 | K160820 | 000 |
| B678520234S0 | K160820 | 000 |
| B678520235S0 | K160820 | 000 |
| B678520236S0 | K160820 | 000 |
| B678520239S0 | K160820 | 000 |
| B678520240S0 | K160820 | 000 |
| B678520228S0 | K160820 | 000 |
| B678520227S0 | K160820 | 000 |
| B678520226S0 | K160820 | 000 |
| B678520216S0 | K160820 | 000 |
| B678520217S0 | K160820 | 000 |
| B678520218S0 | K160820 | 000 |
| B678520219S0 | K160820 | 000 |
| B678520220S0 | K160820 | 000 |
| B678520221S0 | K160820 | 000 |
| B678520223S0 | K160820 | 000 |
| B678520224S0 | K160820 | 000 |
| B678520225S0 | K160820 | 000 |
| B678520241S0 | K160820 | 000 |
| B678520278S0 | K160820 | 000 |
| B678520279S0 | K160820 | 000 |
| B678520292S0 | K160820 | 000 |
| B678520293S0 | K160820 | 000 |
| B678520294S0 | K160820 | 000 |
| B678520295S0 | K160820 | 000 |
| B678520296S0 | K160820 | 000 |
| B678520864S0 | K160820 | 000 |
| B6785202990 | K160820 | 000 |
| B6785203010 | K160820 | 000 |
| B6785203030 | K160820 | 000 |
| B678520291S0 | K160820 | 000 |
| B678520290S0 | K160820 | 000 |
| B678520289S0 | K160820 | 000 |
| B678520280S0 | K160820 | 000 |
| B678520281S0 | K160820 | 000 |
| B678520282S0 | K160820 | 000 |
| B678520283S0 | K160820 | 000 |
| B678520284S0 | K160820 | 000 |
| B678520285S0 | K160820 | 000 |
| B678520286S0 | K160820 | 000 |
| B678520287S0 | K160820 | 000 |
| B678520288S0 | K160820 | 000 |
| B6785203050 | K160820 | 000 |