KNOTILUS ANCHOR SYSTEM

Fastener, Fixation, Nondegradable, Soft Tissue

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd. with the FDA for Knotilus Anchor System.

Pre-market Notification Details

Device IDK113297
510k NumberK113297
Device Name:KNOTILUS ANCHOR SYSTEM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. 291 HILLSIDE AVE. Somerset,  MA  02726
ContactGeorge J Hattub
CorrespondentGeorge J Hattub
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. 291 HILLSIDE AVE. Somerset,  MA  02726
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-08
Decision Date2012-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30810190010014 K113297 000
30810190010007 K113297 000

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