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510(k) K242091

Bolo Button System by Fusion Orthopedics — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2024
Date Received
July 17, 2024
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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