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510(k) K220260

Hercules Syndesmosis Implant System by In2bones USA, LLC — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2022
Date Received
January 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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