Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OrthoGold

K-Number: K191961 · 2019-11-26

ApplicantTissue Regeneration Technologies
Decision Date2019-11-26
Product CodePZL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OrthoGold is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Technologies. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K191961. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoGold?

OrthoGold is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Tissue Regeneration Technologies. The 510(k) number is K191961.

When did OrthoGold receive FDA 510(k) clearance?

OrthoGold received FDA 510(k) clearance on 2019-11-26, under 510(k) number K191961.

Who is the listed applicant for OrthoGold?

The FDA 510(k) record lists Tissue Regeneration Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoGold?

The FDA product code for OrthoGold is PZL.

Other records listing Tissue Regeneration Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210451OrthoGold 100K200926OrthoGold 100K182682OrthoGold 100

Related Devices (Code: PZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.AK250779CS-Pro MEDCurative Sound TherapeuticsK233937OW100SSoftwave/Trt, LLCK231710OW100SSoftwave/Trt, LLCK202112Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpieceStorz Medical AGK200926OrthoGold 100Tissue Regeneration Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑