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FDA 510(k)

CLS VARUS STEM/CLS 135 STEM

K-Number: K010839 · 2001-04-18

ApplicantSulzer Orthopedics, Inc.
Decision Date2001-04-18
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLS VARUS STEM/CLS 135 STEM is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Orthopedics, Inc.. It received FDA 510(k) clearance on 2001-04-18 under 510(k) number K010839. 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 VARUS STEM/CLS 135 STEM?

CLS VARUS STEM/CLS 135 STEM is a medical device that received FDA 510(k) clearance on 2001-04-18. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K010839.

When did CLS VARUS STEM/CLS 135 STEM receive FDA 510(k) clearance?

CLS VARUS STEM/CLS 135 STEM received FDA 510(k) clearance on 2001-04-18, under 510(k) number K010839.

Who is the listed applicant for CLS VARUS STEM/CLS 135 STEM?

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

What is the FDA product code for CLS VARUS STEM/CLS 135 STEM?

The FDA product code for CLS VARUS STEM/CLS 135 STEM is LZO.

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Other records listing Sulzer Orthopedics, 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.

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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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