FDA 510(k) Application Details - K110197

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K110197
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US Other 510(k) Applications for this Company
Contact	VLADISLAVA ZAITSEVA Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2011
Decision Date	07/15/2011
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