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510(k) K222381

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System by Stryker GmbH — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2023
Date Received
August 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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