OrthoGold 100

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Tissue Regeneration Technologies, LLC

The following data is part of a premarket notification filed by Tissue Regeneration Technologies, Llc with the FDA for Orthogold 100.

Pre-market Notification Details

Device IDK200926
510k NumberK200926
Device Name:OrthoGold 100
ClassificationExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Applicant Tissue Regeneration Technologies, LLC 251 Heritage Walk Woodstock,  GA  30188
ContactJohn Warlick
CorrespondentJennifer A. Daudelin
M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York,  NY  10018
Product CodePZL  
CFR Regulation Number878.4685 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-07
Decision Date2020-08-28

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.