OrthoGold

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Tissue Regeneration Technologies

The following data is part of a premarket notification filed by Tissue Regeneration Technologies with the FDA for Orthogold.

Pre-market Notification Details

Device IDK191961
510k NumberK191961
Device Name:OrthoGold
ClassificationExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Applicant Tissue Regeneration Technologies 251 Heritage Walk Woodstock,  GA  30188
ContactJohn Warlick
CorrespondentJennifer A Daudelin
M Squared Associates, Inc 575 Eight Avenue, St 1212 New York,  NY  10018
Product CodePZL  
CFR Regulation Number878.4685 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-23
Decision Date2019-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260484571649 K191961 000

Trademark Results [OrthoGold]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHOGOLD
ORTHOGOLD
85423805 4584802 Live/Registered
Tissue Regeneration Technologies, LLC
2011-09-15
ORTHOGOLD
ORTHOGOLD
78693261 not registered Dead/Abandoned
TISSUE REGENERATION TECHNOLOGIES, LLC
2005-08-16
ORTHOGOLD
ORTHOGOLD
77921295 not registered Dead/Abandoned
Tissue Regeneration Technologies, LLC
2010-01-27
ORTHOGOLD
ORTHOGOLD
76301651 not registered Dead/Abandoned
Senini, Robert J.
2001-08-14
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