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FDA 510(k) Application Details - K200665
Device Classification Name
Intraoperative Orthopedic Joint Assessment Aid
More FDA Info for this Device
510(K) Number
K200665
Device Name
Intraoperative Orthopedic Joint Assessment Aid
Applicant
OrthoSensor, Inc.
1855 Griffin Road Suite A-310
Dania Beach, FL 33004 US
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Contact
Deborah Escobar Johnson
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
03/13/2020
Decision Date
04/12/2020
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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