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510(k) K252312

Eleganz IM Threaded Nail System (IM Threaded Nail System) by Dev4 — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2025
Date Received
July 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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