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FDA 510(k)

Klassic HD Hip System

K-Number: K161073 · 2016-10-19

ApplicantTotal Joint Othopedics, Inc.
Decision Date2016-10-19
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic HD Hip System is a medical device manufactured by Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2016-10-19 under approval number K161073. The device is classified under product code LPH. 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 2016-10-19. It is manufactured by Total Joint Othopedics, Inc.. The 510(k) number is K161073.

When was Klassic HD Hip System approved by the FDA?

Klassic HD Hip System received FDA 510(k) clearance on 2016-10-19, under approval number K161073.

What company makes Klassic HD Hip System?

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

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

The FDA product code for Klassic HD Hip System is LPH.

Other Devices by Total Joint Othopedics, Inc.

K171962Klassic HD® Hip System K191399BIOLOX CONTOURA Ceramic Femoral Head K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post K230537Klassic Knee Revision System K243991Klassic Knee System - Revision Tibial Baseplate

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics

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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