FDA 510(k) Application Details - K100361

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K100361
Device Name	Filler, Bone Void, Calcium Compound
Applicant	PIONEER SURGICAL TECHNOLOGY 11234 EL CAMINO REAL SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	DAVID J COLLETTE, MD Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2010
Decision Date	04/22/2010
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