STRATAFIX Spiral PDS Plus 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 Knotless Tissue Control Device.

Pre-market Notification Details

Device IDK150670
510k NumberK150670
Device Name:STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant ETHICON, INC. ROUTE 22 WEST, PO BOX 151 Somerville,  NJ  08876
ContactDonna Marshall
CorrespondentDonna Marshall
ETHICON, INC. ROUTE 22 WEST, PO BOX 151 Somerville,  NJ  08876
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-16
Decision Date2015-07-02
Summary:summary

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