The following data is part of a premarket notification filed by Pressio, Inc. with the FDA for Uniti Acdf Implant System.
| Device ID | K200301 |
| 510k Number | K200301 |
| Device Name: | UNiTi ACDF Implant System |
| Classification | Anterior Staple As Supplemental Fixation For Fusion |
| Applicant | Pressio, Inc. 14785 Omicron Drive, Suite 100 San Antonio, TX 78245 |
| Contact | Joe Ritz |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | PHQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-06 |
| Decision Date | 2021-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850039803079 | K200301 | 000 |
| 00850039803062 | K200301 | 000 |
| 00850039803055 | K200301 | 000 |
| 00850039803048 | K200301 | 000 |
| 00850039803031 | K200301 | 000 |
| 00850039803024 | K200301 | 000 |
| 00850039803017 | K200301 | 000 |
| 00850039803000 | K200301 | 000 |