Polydioxanone Surgical Scaffold

Mesh, Surgical, Polymeric

Surgical Innovation Associates, Inc.

The following data is part of a premarket notification filed by Surgical Innovation Associates, Inc. with the FDA for Polydioxanone Surgical Scaffold.

Pre-market Notification Details

Device IDK181094
510k NumberK181094
Device Name:Polydioxanone Surgical Scaffold
ClassificationMesh, Surgical, Polymeric
Applicant Surgical Innovation Associates, Inc. 965 West Chicago Ave Chicago,  IL  60642
ContactAlexei Mlodinow
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia,  PA  19103
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-25
Decision Date2018-08-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860000875905 K181094 000
00860000875943 K181094 000
00860000875929 K181094 000

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