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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 the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-08-22 under 510(k) 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. The listed applicant is Zimmer GmbH. The 510(k) number is K192021.

When did NCB Polyaxial Locking Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for NCB Polyaxial Locking Plate System?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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