PROCOTYL® PRIME E-CLASS XLPE Liner
K-Number: K171181 · 2017-08-28
ApplicantMicroport Orthopedics, Inc.
Decision Date2017-08-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PROCOTYL® PRIME E-CLASS XLPE Liner is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-08-28 under approval number K171181. 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 PROCOTYL® PRIME E-CLASS XLPE Liner?
PROCOTYL® PRIME E-CLASS XLPE Liner is a medical device that received FDA 510(k) clearance on 2017-08-28. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K171181.
When was PROCOTYL® PRIME E-CLASS XLPE Liner approved by the FDA?
PROCOTYL® PRIME E-CLASS XLPE Liner received FDA 510(k) clearance on 2017-08-28, under approval number K171181.
What company makes PROCOTYL® PRIME E-CLASS XLPE Liner?
PROCOTYL® PRIME E-CLASS XLPE Liner is manufactured by Microport Orthopedics, Inc..
What is the FDA product code for PROCOTYL® PRIME E-CLASS XLPE Liner?
The FDA product code for PROCOTYL® PRIME E-CLASS XLPE Liner is LZO.
Other Devices by Microport Orthopedics, Inc.
K152631MPO Total Knee Systems MR Labeling
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
K182125EVOLUTION Stemmed CS Femur
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.