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FDA 510(k)

EcoFit® short stem cementless cpTi

K-Number: K240834 · 2024-06-03

ApplicantImplantcast GmbH
Decision Date2024-06-03
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EcoFit® short stem cementless cpTi is a medical device manufactured by Implantcast GmbH. It received FDA 510(k) clearance on 2024-06-03 under approval number K240834. 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 EcoFit® short stem cementless cpTi?

EcoFit® short stem cementless cpTi is a medical device that received FDA 510(k) clearance on 2024-06-03. It is manufactured by Implantcast GmbH. The 510(k) number is K240834.

When was EcoFit® short stem cementless cpTi approved by the FDA?

EcoFit® short stem cementless cpTi received FDA 510(k) clearance on 2024-06-03, under approval number K240834.

What company makes EcoFit® short stem cementless cpTi?

EcoFit® short stem cementless cpTi is manufactured by Implantcast GmbH.

What is the FDA product code for EcoFit® short stem cementless cpTi?

The FDA product code for EcoFit® short stem cementless cpTi is LZO.

Other Devices by Implantcast GmbH

K163577Ecofit® Hip System K180263EcoFit Vit E Acetabular System K191569Implantcast ic-Bipolar Head System K181778MUTARS Proximal Femur Replacement System K191433AGILON® XO Shoulder Replacement System K200045MUTARS Cemented Femoral Stems

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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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