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 Elbow Plating System

K-Number: K231623 · 2023-08-28

ApplicantSkeletal Dynamics, Inc.
Decision Date2023-08-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Distal Elbow Plating System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-08-28 under approval number K231623. 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 Elbow Plating System?

Distal Elbow Plating System is a medical device that received FDA 510(k) clearance on 2023-08-28. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K231623.

When was Distal Elbow Plating System approved by the FDA?

Distal Elbow Plating System received FDA 510(k) clearance on 2023-08-28, under approval number K231623.

What company makes Distal Elbow Plating System?

Distal Elbow Plating System is manufactured by Skeletal Dynamics, Inc..

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

The FDA product code for Distal Elbow 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 NCT03487250 Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System COMPLETED 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

Other Devices by Skeletal Dynamics, Inc.

K201962Skeletal Dynamics Ulnar Shortening Plating System K201662REDUCT® Headless Compression Screw System K200538Skeletal Dynamics Forearm Plating System K200701Skeletal Dynamics Midshaft Humerus Plating System K200367Distal Humerus Plating System K211439Small Bone Nailing System

View all 20 devices →

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.

↑