Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K193307 |
Device Name |
HIP7 |
Applicant |
Brainlab AG |
Olof-Palme-Str. 9 |
Munich,
DE
81829
|
|
Applicant Contact |
Cherita James |
Correspondent |
M Squared Associates Inc. |
575 8th Ave |
Suite 1212 |
New York,
NY
10018
|
|
Correspondent Contact |
Cherita James |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 11/29/2019 |
Decision Date | 06/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|