Device Classification Name |
Cover, Burr Hole
|
510(k) Number |
K240137 |
Device Name |
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System |
Applicant |
Neos Surgery S.L |
Ceramistes 2 |
Cerdanyola,
ES
08290
|
|
Applicant Contact |
Eduard Garcia |
Correspondent |
Neos Surgery S.L |
Ceramistes 2 |
Cerdanyola,
ES
08290
|
|
Correspondent Contact |
Eduard Garcia |
Regulation Number | 882.5250
|
Classification Product Code |
|
Date Received | 01/18/2024 |
Decision Date | 02/16/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|