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510(k) K212545

FlexitSystem Knee osteotomy system by Neosteo — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2022
Date Received
August 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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