FDA.reportPublic FDA data

510(k) K173583

Device
Exactech® Novation® And AcuMatch® E-HXL Acetabular Liners
Applicant
Exactech, Inc.
510(k) number
K173583
Product code
OQI  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-12
Date received
2017-11-20
Regulation
888.3353
Classification name
Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shing Jen Tai
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OQI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252451EPORE® XO cup systemImplantcast GmbH2026-04-24
K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.2020-10-29
K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018-06-12
K111481CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERSCorin USA2012-02-06

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases