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FDA 510(k)

Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners

K-Number: K173583 · 2018-03-12

ApplicantExactech, Inc.
Decision Date2018-03-12
Product CodeOQI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Novation® and AcuMatch® E-HXL Acetabular 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 2018-03-12 under 510(k) number K173583. The device is classified under product code OQI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners?

Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners is a medical device that received FDA 510(k) clearance on 2018-03-12. The listed applicant is Exactech, Inc.. The 510(k) number is K173583.

When did Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners receive FDA 510(k) clearance?

Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners received FDA 510(k) clearance on 2018-03-12, under 510(k) number K173583.

Who is the listed applicant for Exactech® Novation® and AcuMatch® E-HXL Acetabular 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 Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners?

The FDA product code for Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners is OQI.

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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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