510(k) K220334

MONET Anterior Cervical Plate System by Ctl Medical Corporation — Product Code KWQ

K220334 is an FDA 510(k) premarket notification submitted by Ctl Medical Corporation for the device "MONET Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on Nov 9, 2022. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Ctl Medical Corporation has 13 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 9, 2022
Date Received
Feb 4, 2022
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
510(k)

Source: FDA 510(k) database entry for K220334. Report a data issue: hello@regdatalab.com.