Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
510(k) Number |
K142520 |
Device Name |
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software |
Applicant |
Smith & Nephew, Inc |
1450 Brooks Road |
Memphis,
TN
38116
|
|
Applicant Contact |
Martin Ostmann |
Correspondent |
Smith & Nephew, Inc |
1450 Brooks Road |
Memphis,
TN
38116
|
|
Correspondent Contact |
Martin Ostmann |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/08/2014 |
Decision Date | 11/20/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|