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FDA 510(k) Application Details - K133579
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K133579
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
PONTIS ORTHOPAEDICS, LLC
2229 POST STREET, SUITE 103
SAN FRANCISCO, CA 94115 US
Other 510(k) Applications for this Company
Contact
LEONARD GORDON
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/21/2013
Decision Date
06/26/2014
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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