Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K193515 |
Device Name |
Mako Total Knee Application |
Applicant |
Mako Surgical Corp. |
2555 Davie Rd |
Fort Lauderdale,
FL
33317
|
|
Applicant Contact |
Shikha Khandelwal |
Correspondent |
Mako Surgical Corp. |
2555 Davie Rd |
Fort Lauderdale,
FL
33317
|
|
Correspondent Contact |
Shikha Khandelwal |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 12/19/2019 |
Decision Date | 07/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|