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FDA 510(k) Application Details - K182536
Device Classification Name
More FDA Info for this Device
510(K) Number
K182536
Device Name
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
Applicant
Exactech, Inc.
2320 NW 66th Court
Gainesville, FL 32653 US
Other 510(k) Applications for this Company
Contact
Zach Sharrah
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PHX
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More FDA Info for this Product Code
Date Received
09/14/2018
Decision Date
10/12/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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