Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K122326 |
Device Name |
SMARTTOOLS KNEE SYSTEM |
Applicant |
ZIMMER |
75, QUEEN STREET |
SUITE 3300 |
MONTREAL,
CA
H3C 2N6
|
|
Applicant Contact |
CHRISTOPHER MCLEAN |
Correspondent |
ZIMMER |
75, QUEEN STREET |
SUITE 3300 |
MONTREAL,
CA
H3C 2N6
|
|
Correspondent Contact |
CHRISTOPHER MCLEAN |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 08/01/2012 |
Decision Date | 11/30/2012 |
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
|
|
|