510(k) K231715
K231715 is an FDA 510(k) premarket notification submitted by Ctl Medical Corporation for the device "MONDRIAN Anterior Lumbar Plate System". The FDA issued a decision of Substantially Equivalent on January 26, 2024. 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 at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2024
- Date Received
- June 13, 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