Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K220459 |
Device Name |
Mako Total Knee Application |
Applicant |
Mako Surgical Corp. |
3365 Enterprise Ave. |
Weston,
FL
33331
|
|
Applicant Contact |
Emily DiMambro |
Correspondent |
Mako Surgical Corp. |
3365 Enterprise Ave. |
Weston,
FL
33331
|
|
Correspondent Contact |
Emily DiMambro |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 02/17/2022 |
Decision Date | 04/15/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|