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FDA 510(k)

Ulna Plating System

K-Number: K162424 · 2016-10-12

ApplicantBiomet, Inc.
Decision Date2016-10-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ulna Plating System is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2016-10-12 under approval number K162424. 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 Ulna Plating System?

Ulna Plating System is a medical device that received FDA 510(k) clearance on 2016-10-12. It is manufactured by Biomet, Inc.. The 510(k) number is K162424.

When was Ulna Plating System approved by the FDA?

Ulna Plating System received FDA 510(k) clearance on 2016-10-12, under approval number K162424.

What company makes Ulna Plating System?

Ulna Plating System is manufactured by Biomet, Inc..

What is the FDA product code for Ulna Plating System?

The FDA product code for Ulna Plating System is HRS.

Other Devices by Biomet, Inc.

K161592Persona Partial Knee System K161166StageOne Select Cement Spacer Molds for Temporary Hip Replacement K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis K161190G7 Dual Mobility System, Active Articulation System K153657Vanguard XP Knee System K160058Biomet Variable Pitch Compression 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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