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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
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