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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 the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2024-06-03 under 510(k) 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. The listed applicant is Implantcast GmbH. The 510(k) number is K240834.

When did EcoFit® short stem cementless cpTi receive FDA 510(k) clearance?

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

Who is the listed applicant for EcoFit® short stem cementless cpTi?

The FDA 510(k) record lists Implantcast GmbH as the applicant. This does not by itself establish the device manufacturer.

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 records listing Implantcast GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252451EPORE® XO cup systemK260037implantcast Packaging System UpdateK252401implaFit® short stemsK241944AGILON® XO Shoulder Replacement SystemK240391MUTARS® femoral stem cemented 160 mm and 200 mmK234044ACS® LD FB Knee System

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Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx 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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