510(k) K221645

PROstep(TM) MIS 5mm Chamfer Screw System by Wright Medical Technology — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2023
Date Received
June 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