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FDA 510(k)

NOVATION CROWN CUP GXL LINERS

K-Number: K100269 · 2010-05-27

ApplicantExactech, Inc.
Decision Date2010-05-27
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVATION CROWN CUP GXL LINERS is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2010-05-27 under 510(k) number K100269. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVATION CROWN CUP GXL LINERS?

NOVATION CROWN CUP GXL LINERS is a medical device that received FDA 510(k) clearance on 2010-05-27. The listed applicant is Exactech, Inc.. The 510(k) number is K100269.

When did NOVATION CROWN CUP GXL LINERS receive FDA 510(k) clearance?

NOVATION CROWN CUP GXL LINERS received FDA 510(k) clearance on 2010-05-27, under 510(k) number K100269.

Who is the listed applicant for NOVATION CROWN CUP GXL LINERS?

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

What is the FDA product code for NOVATION CROWN CUP GXL LINERS?

The FDA product code for NOVATION CROWN CUP GXL LINERS is LPH.

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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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