Device Classification Name |
growing rod system- magnetic actuation
|
510(k) Number |
K171791 |
Device Name |
MAGEC® System |
Applicant |
NuVasive Specialized Orthopedics, Incorporated |
101 Enterprise |
Suite 100 |
Aliso Viejo,
CA
92656
|
|
Applicant Contact |
Manthan J. Damani |
Correspondent |
NuVasive Specialized Orthopedics, Incorporated |
101 Enterprise, |
Suite 100 |
Aliso Viejo,
CA
92656
|
|
Correspondent Contact |
Manthan J. Damani |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 06/16/2017 |
Decision Date | 08/31/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|