STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

Suture, Surgical, Absorbable, Polydioxanone

Ethicon, Inc.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Stratafix Spiral Pds Plus Bidirectional Knotless Tissue Control Device.

Pre-market Notification Details

Device IDK192144
510k NumberK192144
Device Name:STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville,  NJ  08876 -0151
ContactEleanor Zhou
CorrespondentJoice Pappan
Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville,  NJ  08876 -0151
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-08-08
Decision Date2020-03-25

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