510(k) K261241

TriMed Compression Screws by TriMed, Inc. — Product Code HWC

K261241 is an FDA 510(k) premarket notification submitted by TriMed, Inc. for the device "TriMed Compression Screws". The FDA issued a decision of Substantially Equivalent on May 14, 2026. 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
May 14, 2026
Date Received
April 15, 2026
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