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510(k) K213701

Exeter® X3® RimFit® Cup by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2022
Date Received
November 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

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