Device Classification Name |
neurosurgical nerve locator
|
510(k) Number |
K191723 |
Device Name |
ATEC IOM Accessory Instruments |
Applicant |
Alphatec Spine, Inc. |
5818 El Camino Real |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Ruby Zheng |
Correspondent |
Alphatec Spine, Inc. |
5818 El Camino Real |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Ruby Zheng |
Regulation Number | 874.1820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/27/2019 |
Decision Date | 10/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|