Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K103400 |
Device Name |
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP |
Applicant |
STRYKER CORPORATION |
BOETZINGER STR. 41 |
FREIBURG,
DE
79111
|
|
Applicant Contact |
LILIAN ECKERT |
Correspondent |
STRYKER CORPORATION |
BOETZINGER STR. 41 |
FREIBURG,
DE
79111
|
|
Correspondent Contact |
LILIAN ECKERT |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/19/2010 |
Decision Date | 03/07/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|