THE GRAPPLR AND GRAPPLR EXTENDER

Fastener, Fixation, Nondegradable, Soft Tissue

TAG MEDICAL CORP.

The following data is part of a premarket notification filed by Tag Medical Corp. with the FDA for The Grapplr And Grapplr Extender.

Pre-market Notification Details

Device IDK101616
510k NumberK101616
Device Name:THE GRAPPLR AND GRAPPLR EXTENDER
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant TAG MEDICAL CORP. 291 Hillside Avenue Somerset,  MA  02726
ContactGeorge J Hattub
CorrespondentGeorge J Hattub
TAG MEDICAL CORP. 291 Hillside Avenue Somerset,  MA  02726
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-09
Decision Date2011-01-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10818674025758 K101616 000
10818674025741 K101616 000
10818674025734 K101616 000
10818674025727 K101616 000
10818674025710 K101616 000

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