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

Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented

Exactech, Inc.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech® Novation® And Acumatch® E-hxl Acetabular Liners.

Pre-market Notification Details

• Device ID: K173583
• 510k Number: K173583
• Device Name: Exactech® Novation® And AcuMatch® E-HXL Acetabular Liners
• Classification: Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
• Applicant: Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653
• Contact: Shing Jen Tai
• Correspondent: Shing Jen Tai; Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653
• Product Code: OQI
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-20
• Decision Date: 2018-03-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885862022493	K173583	000
10885862022509	K173583	000
10885862208743	K173583	000
10885862026149	K173583	000
10885862026132	K173583	000
10885862026125	K173583	000
10885862026118	K173583	000
10885862022479	K173583	000
10885862022462	K173583	000
10885862022455	K173583	000
10885862022516	K173583	000
10885862022523	K173583	000
10885862022486	K173583	000
10885862022424	K173583	000
10885862020383	K173583	000
10885862011008	K173583	000
10885862022578	K173583	000
10885862022561	K173583	000
10885862022554	K173583	000
10885862022547	K173583	000
10885862022530	K173583	000
10885862022448	K173583	000