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FDA 510(k)

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly

K-Number: K173104 · 2017-10-27

ApplicantTotal Joint Orthopedics, Inc.
Decision Date2017-10-27
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly is a medical device manufactured by Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-10-27 under approval number K173104. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly?

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Total Joint Orthopedics, Inc.. The 510(k) number is K173104.

When was Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly approved by the FDA?

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly received FDA 510(k) clearance on 2017-10-27, under approval number K173104.

What company makes Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly?

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly is manufactured by Total Joint Orthopedics, Inc..

What is the FDA product code for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly?

The FDA product code for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly is OQG.

Other Devices by Total Joint Orthopedics, Inc.

K162422Klassic Knee System K162256Klassic Femur, Porous, Klassic Tibial Baseplate, Porous K180929Klassic HD® Hip System 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: OQG)

K172651FMP Extended LinersEncore Medical L.P. K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc. K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.

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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