Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K093425 |
Device Name |
MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA |
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 | 11/03/2009 |
Decision Date | 02/24/2010 |
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
|