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FDA 510(k) Application Details - K073688
Device Classification Name
More FDA Info for this Device
510(K) Number
K073688
Device Name
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE, FL 32653 US
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Contact
GRAHAM CUTHBERT
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
12/28/2007
Decision Date
02/29/2008
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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