510(k) K230749

TriMed Threaded Intramedullary Nail System by TriMed, Inc. — Product Code HWC

K230749 is an FDA 510(k) premarket notification submitted by TriMed, Inc. for the device "TriMed Threaded Intramedullary Nail System". The FDA issued a decision of Substantially Equivalent on April 17, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. TriMed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2023
Date Received
March 17, 2023
Clearance Type
Special
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