510(k) K203065

Lumbar Spine Truss System Plating Solution (LSTS-PS) by 4Web, Inc. — Product Code KWQ

K203065 is an FDA 510(k) premarket notification submitted by 4Web, Inc. for the device "Lumbar Spine Truss System Plating Solution (LSTS-PS)". The FDA issued a decision of Substantially Equivalent on March 10, 2021. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. 4Web, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2021
Date Received
October 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type