The following data is part of a premarket notification filed by Longeviti Neuro Solutions, Llc with the FDA for Longeviti Clearfit Cranial Implant.
| Device ID | K203349 |
| 510k Number | K203349 |
| Device Name: | Longeviti ClearFit Cranial Implant |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | Longeviti Neuro Solutions, LLC 303 International Circle Suite 190 Hunt Valley, MD 21030 |
| Contact | Jesse Christopher |
| Correspondent | Elaine Duncan Paladin Medical, Inc P.O. Box 560 Stillwater, MN 55082 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-13 |
| Decision Date | 2020-12-16 |