510(k) K241695

Extremity All Suture System by Field Orthopaedics — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2024
Date Received
June 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type