K200301 is an FDA 510(k) clearance for the UNiTi ACDF Implant System. This device is classified as a Anterior Staple As Supplemental Fixation For Fusion (Class II - Special Controls, product code PHQ).
Submitted by Pressio, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 3, 2021, 363 days after receiving the submission on February 6, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060. Anterior Cervical Device For Supplemental Fixation To Support A Fusion..
| 510(k) Number | K200301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2020 |
| Decision Date | February 03, 2021 |
| Days to Decision | 363 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PHQ - Anterior Staple As Supplemental Fixation For Fusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |
| Definition | Anterior Cervical Device For Supplemental Fixation To Support A Fusion. |