510(k) K212391
K212391 is an FDA 510(k) premarket notification submitted by Mci Medical Concept Innovation, Inc. for the device "MCI-Neuro Fixation System". The FDA issued a decision of Substantially Equivalent on October 21, 2022. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Mci Medical Concept Innovation, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2022
- Date Received
- August 2, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Cranioplasty, Preformed, Alterable
- Device Class
- Class II
- Regulation Number
- 882.5320
- Review Panel
- NE
- Submission Type