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FDA 510(k)

Cemented TSI Hip Stem

K-Number: K181340 · 2019-02-11

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2019-02-11
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cemented TSI Hip Stem is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2019-02-11 under approval number K181340. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cemented TSI Hip Stem?

Cemented TSI Hip Stem is a medical device that received FDA 510(k) clearance on 2019-02-11. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K181340.

When was Cemented TSI Hip Stem approved by the FDA?

Cemented TSI Hip Stem received FDA 510(k) clearance on 2019-02-11, under approval number K181340.

What company makes Cemented TSI Hip Stem?

Cemented TSI Hip Stem is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Cemented TSI Hip Stem?

The FDA product code for Cemented TSI Hip Stem is JDI.

Other Devices by Signature Orthopaedics Pty, Ltd.

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Related Devices (Code: JDI)

K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc. K153725Corin TaperFit Hip StemCorin U.S.A. Limited K153216Alpine Cemented Hip SystemOrtho Development Corporation K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. K180973Libertas Hip Replacement SystemMaxx Orthopedics, 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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