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FDA 510(k)

CLARIS PLATE SYSTEM

K-Number: K010369 · 2001-05-08

ApplicantOrtho Tec, LLC
Decision Date2001-05-08
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLARIS PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Tec, LLC. It received FDA 510(k) clearance on 2001-05-08 under 510(k) number K010369. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARIS PLATE SYSTEM?

CLARIS PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-08. The listed applicant is Ortho Tec, LLC. The 510(k) number is K010369.

When did CLARIS PLATE SYSTEM receive FDA 510(k) clearance?

CLARIS PLATE SYSTEM received FDA 510(k) clearance on 2001-05-08, under 510(k) number K010369.

Who is the listed applicant for CLARIS PLATE SYSTEM?

The FDA 510(k) record lists Ortho Tec, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARIS PLATE SYSTEM?

The FDA product code for CLARIS PLATE SYSTEM is MNH. This falls under the ENT category.

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Other records listing Ortho Tec, LLC as applicant

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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Related Devices (Code: MNH)

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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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