510(k) K221283

Hammertoe Truss System (HTS) by 4Web Medical, Inc. — Product Code HTY

K221283 is an FDA 510(k) premarket notification submitted by 4Web Medical, Inc. for the device "Hammertoe Truss System (HTS)". The FDA issued a decision of Substantially Equivalent on September 6, 2022. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. 4Web Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2022
Date Received
May 3, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type