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FDA 510(k)

IlluminOss Bone Stabilization System

K-Number: K181228 · 2018-08-31

ApplicantIlluminoss Medical, Inc.
Decision Date2018-08-31
Product CodeQAD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IlluminOss Bone Stabilization System is a medical device manufactured by Illuminoss Medical, Inc.. It received FDA 510(k) clearance on 2018-08-31 under approval number K181228. 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 Bone Stabilization System?

IlluminOss Bone Stabilization System is a medical device that received FDA 510(k) clearance on 2018-08-31. It is manufactured by Illuminoss Medical, Inc.. The 510(k) number is K181228.

When was IlluminOss Bone Stabilization System approved by the FDA?

IlluminOss Bone Stabilization System received FDA 510(k) clearance on 2018-08-31, under approval number K181228.

What company makes IlluminOss Bone Stabilization System?

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

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

The FDA product code for IlluminOss 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 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: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023)

Other Devices by Illuminoss Medical, Inc.

K183145IlluminOss Photodynamic Bone Stabilization System K202887IlluminOss Bone Stabilization System K201961IlluminOss Photodynamic 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. K202887IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. K201961IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. K200295IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. K233436IlluminOss Photodynamic 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.

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