Device Classification Name |
growing rod system- magnetic actuation
|
510(k) Number |
K233593 |
Device Name |
MAGEC Spinal Bracing and Distraction System |
Applicant |
NuVasive Specialized Orthopedics, Incorporated |
101 Enterprise |
Suite 100 |
Aliso Viejo,
CA
92656
|
|
Applicant Contact |
Miriam Cervantes |
Correspondent |
NuVasive Specialized Orthopedics, Incorporated |
101 Enterprise |
Suite 100 |
Aliso Viejo,
CA
92656
|
|
Correspondent Contact |
Miriam Cervantes |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 11/08/2023 |
Decision Date | 02/06/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|