Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K081867 |
Device Name |
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 |
Applicant |
MAKO SURGICAL CORP. |
2555 DAVIE RD. |
FORT LAUDERDALE,
FL
33317
|
|
Applicant Contact |
WILLIAM TAPIA |
Correspondent |
MAKO SURGICAL CORP. |
2555 DAVIE RD. |
FORT LAUDERDALE,
FL
33317
|
|
Correspondent Contact |
WILLIAM TAPIA |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 07/01/2008 |
Decision Date | 11/25/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|