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510(k) K111785

FREEDOM(R) STEMMED TIBIAL COMPONENTS by Maxx Orthopedics, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2012
Date Received
June 24, 2011
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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  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
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