Device Classification Name |
cranial distraction system
|
510(k) Number |
K230211 |
Device Name |
CranioXpand |
Applicant |
KLS-Martin L.P. |
11201 Saint Johns Industrial Pkwy S |
Jacksonville,
FL
32246
|
|
Applicant Contact |
Melissa Bachorski |
Correspondent |
KLS-Martin L.P. |
11201 Saint Johns Industrial Pkwy S |
Jacksonville,
FL
32246
|
|
Correspondent Contact |
Daphne Vincent |
Regulation Number | 882.5330
|
Classification Product Code |
|
Date Received | 01/26/2023 |
Decision Date | 11/21/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|