TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)

Mesh, Surgical, Polymeric

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Tyrx Neuro Absorbable Antibacterial Envelope (medium); Tyrx Neuro Absorbable Antibacterial Envelope (large).

Pre-market Notification Details

Device IDK180122
510k NumberK180122
Device Name:TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
ClassificationMesh, Surgical, Polymeric
Applicant Medtronic, Inc. 8200 Coral Sea St. NE Mounds View,  MN  55112
ContactNancy Cameron
CorrespondentNancy Cameron
Medtronic, Inc. 8200 Coral Sea St. NE Mounds View,  MN  55112
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2018-01-16
Decision Date2018-06-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000101633 K180122 000
00763000101626 K180122 000
00763000307905 K180122 000
00763000307899 K180122 000

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