Device Classification Name |
neurological stereotaxic instrument
|
510(k) Number |
K022579 |
Device Name |
STRYKER NAVIGATION SYSTEM-KNEE MODULE |
Applicant |
STRYKER LEIBINGER |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
KELLI J BITTERBURG |
Correspondent |
STRYKER LEIBINGER |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
KELLI J BITTERBURG |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 08/05/2002 |
Decision Date | 06/02/2003 |
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
|