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FDA 510(k)

Cemented TSI Hip Stem

K-Number: K192024 · 2020-06-19

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2020-06-19
Product CodeLZO
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 2020-06-19 under approval number K192024. 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 Cemented TSI Hip Stem?

Cemented TSI Hip Stem is a medical device that received FDA 510(k) clearance on 2020-06-19. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K192024.

When was Cemented TSI Hip Stem approved by the FDA?

Cemented TSI Hip Stem received FDA 510(k) clearance on 2020-06-19, under approval number K192024.

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 LZO.

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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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