510(k) K220376

Acetabular Dome Hole Plug by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2022
Date Received
February 10, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type