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FDA 510(k)

ORIA ZENITH

K-Number: K030500 · 2003-03-20

ApplicantOrtho Tec, LLC
Decision Date2003-03-20
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORIA ZENITH 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 2003-03-20 under 510(k) number K030500. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORIA ZENITH?

ORIA ZENITH is a medical device that received FDA 510(k) clearance on 2003-03-20. The listed applicant is Ortho Tec, LLC. The 510(k) number is K030500.

When did ORIA ZENITH receive FDA 510(k) clearance?

ORIA ZENITH received FDA 510(k) clearance on 2003-03-20, under 510(k) number K030500.

Who is the listed applicant for ORIA ZENITH?

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 ORIA ZENITH?

The FDA product code for ORIA ZENITH is KWQ.

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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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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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