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510(k) K202207

Materialise PKA Guide System by Materialise NV — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2020
Date Received
August 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

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