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FDA 510(k)

Proximal Humerus Fixation System

K-Number: K242436 · 2024-11-14

ApplicantSkeletal Dynamics, Inc.
Decision Date2024-11-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Proximal Humerus Fixation System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2024-11-14 under approval number K242436. 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 Proximal Humerus Fixation System?

Proximal Humerus Fixation System is a medical device that received FDA 510(k) clearance on 2024-11-14. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K242436.

When was Proximal Humerus Fixation System approved by the FDA?

Proximal Humerus Fixation System received FDA 510(k) clearance on 2024-11-14, under approval number K242436.

What company makes Proximal Humerus Fixation System?

Proximal Humerus Fixation System is manufactured by Skeletal Dynamics, Inc..

What is the FDA product code for Proximal Humerus Fixation System?

The FDA product code for Proximal Humerus Fixation System is HRS.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT01866501 Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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

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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.

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