Tenodesis Screw System

Fastener, Fixation, Nondegradable, Soft Tissue

Paragon 28,Inc.

The following data is part of a premarket notification filed by Paragon 28,inc. with the FDA for Tenodesis Screw System.

Pre-market Notification Details

Device IDK183690
510k NumberK183690
Device Name:Tenodesis Screw System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Paragon 28,Inc. 4B Inverness Ct. E, STE 280 Englewood,  CO  80112
ContactEric Lintula
CorrespondentEric Lintula
Paragon 28,Inc. 4B Inverness Ct. E, STE 280 Englewood,  CO  80112
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-31
Decision Date2019-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889795107527 K183690 000
00889795107510 K183690 000
00889795106315 K183690 000

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