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FDA 510(k)

Klassic HD® Hip System

K-Number: K180929 · 2018-05-09

ApplicantTotal Joint Orthopedics, Inc.
Decision Date2018-05-09
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic HD® Hip System is a medical device manufactured by Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-05-09 under approval number K180929. 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 Klassic HD® Hip System?

Klassic HD® Hip System is a medical device that received FDA 510(k) clearance on 2018-05-09. It is manufactured by Total Joint Orthopedics, Inc.. The 510(k) number is K180929.

When was Klassic HD® Hip System approved by the FDA?

Klassic HD® Hip System received FDA 510(k) clearance on 2018-05-09, under approval number K180929.

What company makes Klassic HD® Hip System?

Klassic HD® Hip System is manufactured by Total Joint Orthopedics, Inc..

What is the FDA product code for Klassic HD® Hip System?

The FDA product code for Klassic HD® Hip System is LZO.

Other Devices by Total Joint Orthopedics, Inc.

K162422Klassic Knee System K162256Klassic Femur, Porous, Klassic Tibial Baseplate, Porous K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly K180159Klassic® Knee System K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly

View all 11 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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