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 ID: K191961
• 510k Number: K191961
• Device Name: OrthoGold
• Classification: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
• Applicant: Tissue Regeneration Technologies 251 Heritage Walk Woodstock, GA 30188
• Contact: John Warlick
• Correspondent: Jennifer A Daudelin; M Squared Associates, Inc 575 Eight Avenue, St 1212 New York, NY 10018
• Product Code: PZL
• CFR Regulation Number: 878.4685 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-23
• Decision Date: 2019-11-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04260484571649	K191961	000