Device Classification Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K082172 |
Device Name |
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM |
Applicant |
MAKO SURGICAL CORPORATION |
2555 DAVIE ROAD |
FORT LAUDERDALE,
FL
33317
|
|
Applicant Contact |
WILLIAM F TAPIA |
Correspondent |
MAKO SURGICAL CORPORATION |
2555 DAVIE ROAD |
FORT LAUDERDALE,
FL
33317
|
|
Correspondent Contact |
WILLIAM F TAPIA |
Regulation Number | 888.3520
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/01/2008 |
Decision Date | 11/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|