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510(k) K190181

Instruments for LINK MEGASYSTEM-C Family by LinkBio Corp. — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2019
Date Received
February 1, 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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