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FDA 510(k) Application Details - K092900
Device Classification Name
More FDA Info for this Device
510(K) Number
K092900
Device Name
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE, FL 32653 US
Other 510(k) Applications for this Company
Contact
TARA R PATTERSON
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/2009
Decision Date
01/07/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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