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FDA 510(k) Application Details - K193098
Device Classification Name
More FDA Info for this Device
510(K) Number
K193098
Device Name
Exactech« Equinoxe« Reverse Shoulder Glenospheres
Applicant
Exactech, Inc
2320 NW 66th Court
Gainesville, FL 32653 US
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Contact
Zach Sharrah
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PHX
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Date Received
11/07/2019
Decision Date
02/20/2020
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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