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FDA 510(k)

NCB Polyaxial Locking Plate System

K-Number: K192021 · 2019-08-22

ApplicantZimmer GmbH
Decision Date2019-08-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NCB Polyaxial Locking Plate System is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2019-08-22 under approval number K192021. 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 Polyaxial Locking Plate System?

NCB Polyaxial Locking Plate System is a medical device that received FDA 510(k) clearance on 2019-08-22. It is manufactured by Zimmer GmbH. The 510(k) number is K192021.

When was NCB Polyaxial Locking Plate System approved by the FDA?

NCB Polyaxial Locking Plate System received FDA 510(k) clearance on 2019-08-22, under approval number K192021.

What company makes NCB Polyaxial Locking Plate System?

NCB Polyaxial Locking Plate System is manufactured by Zimmer GmbH.

What is the FDA product code for NCB Polyaxial Locking Plate System?

The FDA product code for NCB Polyaxial Locking Plate System is HRS.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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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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