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 | K191210 |
510k Number | K191210 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-06 |
Decision Date | 2020-01-09 |