FDA 510(k) Application Details - K110708

Device Classification Name	More FDA Info for this Device
510(K) Number	K110708
Device Name	EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
Applicant	EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US Other 510(k) Applications for this Company
Contact	LINDY KNISELY Other 510(k) Applications for this Contact
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	03/14/2011
Decision Date	04/01/2011
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