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FDA 510(k)

Prime E-CLASS XLPE Liner

K-Number: K181598 · 2018-09-14

ApplicantMicroport Orthopedics, Inc.
Decision Date2018-09-14
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prime E-CLASS XLPE Liner is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-09-14 under approval number K181598. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prime E-CLASS XLPE Liner?

Prime E-CLASS XLPE Liner is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K181598.

When was Prime E-CLASS XLPE Liner approved by the FDA?

Prime E-CLASS XLPE Liner received FDA 510(k) clearance on 2018-09-14, under approval number K181598.

What company makes Prime E-CLASS XLPE Liner?

Prime E-CLASS XLPE Liner is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for Prime E-CLASS XLPE Liner?

The FDA product code for Prime E-CLASS XLPE Liner is LZO.

Other Devices by Microport Orthopedics, Inc.

K152631MPO Total Knee Systems MR Labeling K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner K171389EVOLUTION Revision CCK System K170444PROCOTYL® PRIME Acetabular Cup System K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

View all 28 devices →

Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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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