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 a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2018-03-12 under approval 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. It is manufactured by Exactech, Inc.. The 510(k) number is K173583.
When was Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners approved by the FDA?
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners received FDA 510(k) clearance on 2018-03-12, under approval number K173583.
What company makes Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners?
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners is manufactured by Exactech, Inc..
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.
Other Devices by Exactech, Inc.
Related Devices (Code: OQI)
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.