510(k) K181562

Curiteva Anterior Cervical Plate System by Curiteva, LLC — Product Code KWQ

K181562 is an FDA 510(k) premarket notification submitted by Curiteva, LLC for the device "Curiteva Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on August 2, 2018. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Curiteva, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2018
Date Received
June 14, 2018
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