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510(k) K192798

Zimmer Segmental System by Zimmer, Inc. — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2020
Date Received
September 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

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  • K223069 — Modular Rotating Hinge Knee Systems and Compatible Components (April 21, 2023)
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