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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 a medical device manufactured by Illuminoss Medical, Inc.. It received FDA 510(k) clearance on 2020-08-13 under approval 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. It is manufactured by Illuminoss Medical, Inc.. The 510(k) number is K201961.

When was IlluminOss Photodynamic Bone Stabilization System approved by the FDA?

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

What company makes IlluminOss Photodynamic Bone Stabilization System?

IlluminOss Photodynamic Bone Stabilization System is manufactured by Illuminoss Medical, Inc..

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

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06807359 Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System RECRUITING NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT05206981 Device Global Registry for the IlluminOss Bone Stabilization System RECRUITING NCT06939374 Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study RECRUITING

Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Illuminoss Medical, Inc.

K183145IlluminOss Photodynamic Bone Stabilization System K181228IlluminOss Bone Stabilization System K202887IlluminOss Bone Stabilization System K200295IlluminOss Bone Stabilization System K233436IlluminOss Photodynamic Bone Stabilization System

Related Devices (Code: QAD)

DEN160062IlluminOss Bone Stabilization SystemIllminoss Medical, Inc. K183145IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. K181228IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. K202887IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. K200295IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. K233436IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc.

Official Source

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

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