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FDA 510(k)

NCB Plating System Distal Femur and Proximal Tibia

K-Number: K192217 · 2019-09-13

ApplicantZimmer GmbH
Decision Date2019-09-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NCB Plating System Distal Femur and Proximal Tibia is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2019-09-13 under approval number K192217. 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 NCB Plating System Distal Femur and Proximal Tibia?

NCB Plating System Distal Femur and Proximal Tibia is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Zimmer GmbH. The 510(k) number is K192217.

When was NCB Plating System Distal Femur and Proximal Tibia approved by the FDA?

NCB Plating System Distal Femur and Proximal Tibia received FDA 510(k) clearance on 2019-09-13, under approval number K192217.

What company makes NCB Plating System Distal Femur and Proximal Tibia?

NCB Plating System Distal Femur and Proximal Tibia is manufactured by Zimmer GmbH.

What is the FDA product code for NCB Plating System Distal Femur and Proximal Tibia?

The FDA product code for NCB Plating System Distal Femur and Proximal Tibia is HRS.

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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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