HammerTube System

Pin, Fixation, Smooth

Paragon 28

The following data is part of a premarket notification filed by Paragon 28 with the FDA for Hammertube System.

Pre-market Notification Details

Device IDK171715
510k NumberK171715
Device Name:HammerTube System
ClassificationPin, Fixation, Smooth
Applicant Paragon 28 4B Inverness Ct. E., STE 280 Englewood,  CO  80112
ContactFrank S. Bono
CorrespondentKaren E. Warden
BackRoads Consulting, Inc PO Box 566 Chesterland,  OH  44026 -0566
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-09
Decision Date2018-03-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00889795034069 K171715 000
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00889795057723 K171715 000
00889795128416 K171715 000

Trademark Results [HammerTube System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAMMERTUBE SYSTEM
HAMMERTUBE SYSTEM
87715733 5464721 Live/Registered
PARAGON 28, INC.
2017-12-11

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