Device Classification Name |
plate, cranioplasty, preformed, non-alterable
|
510(k) Number |
K191210 |
Device Name |
Longeviti ClearFit Cranial Implant |
Applicant |
Longeviti Neuro Solutions, LLC |
303 International Circle Suite 190 |
Hunt Valley,
MD
21030
|
|
Applicant Contact |
Jesse Christopher |
Correspondent |
Paladin Medical, Inc. |
P.O. Box 560 |
Stillwater,
MN
55082
|
|
Correspondent Contact |
Elaine Duncan |
Regulation Number | 882.5330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/06/2019 |
Decision Date | 01/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|