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)

IlluminOss Photodynamic Bone Stabilization System

K-Number: K201961 · 2020-08-13

ApplicantIlluminoss Medical, Inc.
Decision Date2020-08-13
Product CodeQAD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IlluminOss Photodynamic Bone Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Illuminoss Medical, Inc.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K201961. The device is classified under product code QAD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IlluminOss Photodynamic Bone Stabilization System?

IlluminOss Photodynamic Bone Stabilization System is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Illuminoss Medical, Inc.. The 510(k) number is K201961.

When did IlluminOss Photodynamic Bone Stabilization System receive FDA 510(k) clearance?

IlluminOss Photodynamic Bone Stabilization System received FDA 510(k) clearance on 2020-08-13, under 510(k) number K201961.

Who is the listed applicant for IlluminOss Photodynamic Bone Stabilization System?

The FDA 510(k) record lists Illuminoss Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IlluminOss Photodynamic Bone Stabilization System?

The FDA product code for IlluminOss Photodynamic Bone Stabilization System is QAD.

Related Clinical Trials

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.

NCT02373904A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone DiseaseTERMINATEDNCT02394080Safety and Efficacy Study of the Treatment of Humerus FracturesCOMPLETEDNCT05206981Device Global Registry for the IlluminOss Bone Stabilization SystemRECRUITING

Other records listing Illuminoss Medical, Inc. 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.

K233436IlluminOss Photodynamic Bone Stabilization SystemK202887IlluminOss Bone Stabilization SystemK200295IlluminOss Bone Stabilization SystemK183145IlluminOss Photodynamic Bone Stabilization SystemK181228IlluminOss Bone Stabilization System

Related Devices (Code: QAD)

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.

K233436IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc.K202887IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc.K200295IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc.K183145IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc.K181228IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc.

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.

↑