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FDA 510(k)

Distal Humerus Plating System

K-Number: K200367 · 2020-05-14

ApplicantSkeletal Dynamics, Inc.
Decision Date2020-05-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Distal Humerus Plating System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2020-05-14 under approval number K200367. 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 Humerus Plating System?

Distal Humerus Plating System is a medical device that received FDA 510(k) clearance on 2020-05-14. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K200367.

When was Distal Humerus Plating System approved by the FDA?

Distal Humerus Plating System received FDA 510(k) clearance on 2020-05-14, under approval number K200367.

What company makes Distal Humerus Plating System?

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

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

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

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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 K211439Small Bone Nailing System K220723Hand Trauma Screw 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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