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FDA 510(k)

APEX MODULAR ALUMINA FEMORAL HEAD

K-Number: K012918 · 2001-11-27

ApplicantApex Surgical, LLC
Decision Date2001-11-27
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX MODULAR ALUMINA FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Apex Surgical, LLC. It received FDA 510(k) clearance on 2001-11-27 under 510(k) number K012918. 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 APEX MODULAR ALUMINA FEMORAL HEAD?

APEX MODULAR ALUMINA FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2001-11-27. The listed applicant is Apex Surgical, LLC. The 510(k) number is K012918.

When did APEX MODULAR ALUMINA FEMORAL HEAD receive FDA 510(k) clearance?

APEX MODULAR ALUMINA FEMORAL HEAD received FDA 510(k) clearance on 2001-11-27, under 510(k) number K012918.

Who is the listed applicant for APEX MODULAR ALUMINA FEMORAL HEAD?

The FDA 510(k) record lists Apex Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APEX MODULAR ALUMINA FEMORAL HEAD?

The FDA product code for APEX MODULAR ALUMINA FEMORAL HEAD 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 Apex Surgical, LLC 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.

K043123APEX MODULAR HA HIP STEMK041950APEX K2 HIP SYSTEMK031110APEX MODULAR ACETABULAR CUPK003923APEX MODULAR ZIRCONIA FEMORAL HEADK000788APEX MODULAR HIP STEM

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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