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FDA 510(k)

STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD

K-Number: K033944 · 2004-03-12

ApplicantStelkast Company
Decision Date2004-03-12
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 2004-03-12 under 510(k) number K033944. 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 STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD?

STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2004-03-12. The listed applicant is Stelkast Company. The 510(k) number is K033944.

When did STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD receive FDA 510(k) clearance?

STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD received FDA 510(k) clearance on 2004-03-12, under 510(k) number K033944.

Who is the listed applicant for STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD?

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

What is the FDA product code for STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD?

The FDA product code for STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD is LZO.

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Other records listing Stelkast Company 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.

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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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink 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 GmbH

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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