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FDA 510(k)

implantcast Packaging System Update

K-Number: K260037 · 2026-03-30

ApplicantImplantcast GmbH
Decision Date2026-03-30
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

implantcast Packaging System Update is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2026-03-30 under 510(k) number K260037. 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 implantcast Packaging System Update?

implantcast Packaging System Update is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Implantcast GmbH. The 510(k) number is K260037.

When did implantcast Packaging System Update receive FDA 510(k) clearance?

implantcast Packaging System Update received FDA 510(k) clearance on 2026-03-30, under 510(k) number K260037.

Who is the listed applicant for implantcast Packaging System Update?

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 implantcast Packaging System Update?

The FDA product code for implantcast Packaging System Update is LZO.

Other records listing Implantcast GmbH as applicant

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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.K252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.K250450Coated hip implantsMedacta International S.A.

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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