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FDA 510(k) Application Details - K192041
Device Classification Name
Bone Cement, Antibiotic
More FDA Info for this Device
510(K) Number
K192041
Device Name
Bone Cement, Antibiotic
Applicant
G21 S.r.l
Via Sandro Petrini, 8
San Possidonio 41039 IT
Other 510(k) Applications for this Company
Contact
Filippo Foroni
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
MBB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/31/2019
Decision Date
10/29/2019
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
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