ECLIPSE SOFT TISSUE FASTENER

Fastener, Fixation, Nondegradable, Soft Tissue

MEDSHAPE, INC

The following data is part of a premarket notification filed by Medshape, Inc with the FDA for Eclipse Soft Tissue Fastener.

Pre-market Notification Details

Device IDK123350
510k NumberK123350
Device Name:ECLIPSE SOFT TISSUE FASTENER
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant MEDSHAPE, INC 1575 NORTHSIDE DRIVE, SUITE 440 Atlanta,  GA  30318
ContactJack C Griffis Iii
CorrespondentJack C Griffis Iii
MEDSHAPE, INC 1575 NORTHSIDE DRIVE, SUITE 440 Atlanta,  GA  30318
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-31
Decision Date2013-03-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M970150000092000 K123350 000
M970150000041700 K123350 000
M970150000051207 K123350 000
M970150000052006 K123350 000
M970150000061208 K123350 000
M970150000062007 K123350 000
M970150000071209 K123350 000
M970150000072008 K123350 000
M970150000081200 K123350 000
M970150000082009 K123350 000
M970150000091500 K123350 000
M970150000041004 K123350 000

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