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510(k) K221337

Materialise TKA Guide System by Materialise NV — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2022
Date Received
May 9, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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