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510(k) K222835

Prophecy Preoperative Navigation Alignment System by Wrightmedicaltechnologyinc — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2023
Date Received
September 20, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3110
Review Panel
OR
Submission Type

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