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

FDA 510(k)

Distal Radius Plating System

K-Number: K182810 · 2018-12-10

ApplicantMiami Device Solutions, LLC
Decision Date2018-12-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Distal Radius Plating System is a medical device manufactured by Miami Device Solutions, LLC. It received FDA 510(k) clearance on 2018-12-10 under approval number K182810. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Distal Radius Plating System?

Distal Radius Plating System is a medical device that received FDA 510(k) clearance on 2018-12-10. It is manufactured by Miami Device Solutions, LLC. The 510(k) number is K182810.

When was Distal Radius Plating System approved by the FDA?

Distal Radius Plating System received FDA 510(k) clearance on 2018-12-10, under approval number K182810.

What company makes Distal Radius Plating System?

Distal Radius Plating System is manufactured by Miami Device Solutions, LLC.

What is the FDA product code for Distal Radius Plating System?

The FDA product code for Distal Radius Plating System is HRS.

Related Clinical Trials

NCT07211035 Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1) RECRUITING NCT07431723 Creation of Compression Anastomosis Using the GT Metabolic Magnet System RECRUITING NCT06977035 Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib RECRUITING NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT07538141 The Hyalex MTP Study RECRUITING NCT06136286 ORIF Distal Radius Blood Flow Restriction Therapy ACTIVE_NOT_RECRUITING

Other Devices by Miami Device Solutions, LLC

K162635Distal Radius Plating System K161292Distal Radius Plating System K161058Cannulated Screw K172786MDS Plating System K162898Olecranon Plating System

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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.

↑