Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K142530 |
Device Name |
Partial Knee Application (PKA) |
Applicant |
MAKO SURGICAL CORPORATION |
2555 DAVIE ROAD |
FORT LAUDERDALE,
FL
33317
|
|
Applicant Contact |
Jonathan Reeves |
Correspondent |
MAKO SURGICAL CORPORATION |
2555 DAVIE ROAD |
FORT LAUDERDALE,
FL
33317
|
|
Correspondent Contact |
Jonathan Reeves |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 09/09/2014 |
Decision Date | 09/16/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|