Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K121064 |
Device Name |
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM |
Applicant |
MAKO SURGICAL CORPORATION |
2555 DAVIE ROAD |
FORT LAUDERDALE,
FL
33317
|
|
Applicant Contact |
DIONNE SANDERS |
Correspondent |
MAKO SURGICAL CORPORATION |
2555 DAVIE ROAD |
FORT LAUDERDALE,
FL
33317
|
|
Correspondent Contact |
DIONNE SANDERS |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 04/06/2012 |
Decision Date | 06/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|