510(k) K240388

Osteotomy Truss System (OTS) by 4Web Medical, Inc. — Product Code HRS

K240388 is an FDA 510(k) premarket notification submitted by 4Web Medical, Inc. for the device "Osteotomy Truss System (OTS)". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. 4Web Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
February 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type