510(k) K221645
K221645 is an FDA 510(k) premarket notification submitted by Wright Medical Technology for the device "PROstep(TM) MIS 5mm Chamfer Screw System". The FDA issued a decision of Substantially Equivalent on Feb 17, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 17, 2023
- Date Received
- Jun 6, 2022
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)