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FDA 510(k) Application Details - K131767
Device Classification Name
Intraoperative Orthopedic Joint Assessment Aid
More FDA Info for this Device
510(K) Number
K131767
Device Name
Intraoperative Orthopedic Joint Assessment Aid
Applicant
ORTHOSENSOR, INC.
1855 GRIFFIN ROAD
SUITE A-310
DANIA BEACH, FL 33004-2200 US
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Contact
MARTHA I GARAY
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
ONN
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More FDA Info for this Product Code
Date Received
06/17/2013
Decision Date
11/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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