510(k) K212527

Cervical Spine Truss System Plating Solution (CSTS-PS) by 4Web Medical, Inc. — Product Code KWQ

K212527 is an FDA 510(k) premarket notification submitted by 4Web Medical, Inc. for the device "Cervical Spine Truss System Plating Solution (CSTS-PS)". The FDA issued a decision of Substantially Equivalent on May 17, 2022. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. 4Web Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2022
Date Received
August 11, 2021
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