510(k) K203349
K203349 is an FDA 510(k) premarket notification submitted by Longeviti Neuro Solutions, LLC for the device "Longeviti ClearFit Cranial Implant". The FDA issued a decision of Substantially Equivalent on December 16, 2020. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Longeviti Neuro Solutions, LLC has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2020
- Date Received
- November 13, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Device Class
- Class II
- Regulation Number
- 882.5330
- Review Panel
- NE
- Submission Type