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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filler, bone void, calcium compound
510(k) Number K110561
Device Name FORTROSS BONE VOID FILLER
Applicant
PIONEER SURGICAL TECHNOLOGY
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact DAVID J COLLETTE
Correspondent
PIONEER SURGICAL TECHNOLOGY
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact DAVID J COLLETTE
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/28/2011
Decision Date 04/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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