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FDA 510(k)

CLS SPOTORNO STEM

K-Number: K042249 · 2004-09-15

ApplicantZimmer Austin, Inc.
Decision Date2004-09-15
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLS SPOTORNO STEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Austin, Inc.. It received FDA 510(k) clearance on 2004-09-15 under 510(k) number K042249. 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 CLS SPOTORNO STEM?

CLS SPOTORNO STEM is a medical device that received FDA 510(k) clearance on 2004-09-15. The listed applicant is Zimmer Austin, Inc.. The 510(k) number is K042249.

When did CLS SPOTORNO STEM receive FDA 510(k) clearance?

CLS SPOTORNO STEM received FDA 510(k) clearance on 2004-09-15, under 510(k) number K042249.

Who is the listed applicant for CLS SPOTORNO STEM?

The FDA 510(k) record lists Zimmer Austin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLS SPOTORNO STEM?

The FDA product code for CLS SPOTORNO STEM is LZO.

Related Clinical Trials

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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Other records listing Zimmer Austin, Inc. 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.

K043356WAGNER SL REVISION STEM LATERAL

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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