MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS

Fastener, Fixation, Nondegradable, Soft Tissue

PONTIS ORTHOPAEDICS, LLC

The following data is part of a premarket notification filed by Pontis Orthopaedics, Llc with the FDA for Multifilament Stainless Steel Sutures With Crimps.

Pre-market Notification Details

Device IDK133579
510k NumberK133579
Device Name:MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant PONTIS ORTHOPAEDICS, LLC 2229 POST STREET, SUITE 103 San Francisco,  CA  94115
ContactLeonard Gordon
CorrespondentLeonard Gordon
PONTIS ORTHOPAEDICS, LLC 2229 POST STREET, SUITE 103 San Francisco,  CA  94115
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-21
Decision Date2014-06-26
Summary:summary

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