510(k) K200301
K200301 is an FDA 510(k) premarket notification submitted by Pressio, Inc. for the device "UNiTi ACDF Implant System". The FDA issued a decision of Substantially Equivalent on February 3, 2021. The device falls under product code PHQ (Anterior Staple As Supplemental Fixation For Fusion), a Class II device regulated under 21 CFR 888.3060.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2021
- Date Received
- February 6, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anterior Staple As Supplemental Fixation For Fusion
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
Anterior cervical device for supplemental fixation to support a fusion.