510(k) K243624

Acu-Sinch Knotless Mini by Acumed, LLC — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2025
Date Received
November 25, 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