510(k) K233360

Curiteva Thoracolumbar Plate System by Curiteva, Inc. — Product Code KWQ

K233360 is an FDA 510(k) premarket notification submitted by Curiteva, Inc. for the device "Curiteva Thoracolumbar Plate System". The FDA issued a decision of Substantially Equivalent on February 29, 2024. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Curiteva, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2024
Date Received
September 29, 2023
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