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510(k) K242984

BKS Revision System by Ortho Development Corp. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2024
Date Received
September 26, 2024
Clearance Type
Special
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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