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510(k) K260274

Airlock® Ankle Plating System by Novastep SAS — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2026
Date Received
January 29, 2026
Clearance Type
Abbreviated
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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