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510(k) K123380

STRIDE UNICONDYLAR KNEE by Blue Belt Technologies, Inc. — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2013
Date Received
November 1, 2012
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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