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FDA 510(k)

PCA ALUMINA FEMORAL HEADS

K-Number: K063816 · 2007-02-02

ApplicantStryker Orthopaedics
Decision Date2007-02-02
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PCA ALUMINA FEMORAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2007-02-02 under 510(k) number K063816. 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 PCA ALUMINA FEMORAL HEADS?

PCA ALUMINA FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 2007-02-02. The listed applicant is Stryker Orthopaedics. The 510(k) number is K063816.

When did PCA ALUMINA FEMORAL HEADS receive FDA 510(k) clearance?

PCA ALUMINA FEMORAL HEADS received FDA 510(k) clearance on 2007-02-02, under 510(k) number K063816.

Who is the listed applicant for PCA ALUMINA FEMORAL HEADS?

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

What is the FDA product code for PCA ALUMINA FEMORAL HEADS?

The FDA product code for PCA ALUMINA FEMORAL HEADS is LZO.

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Other records listing Stryker Orthopaedics as applicant

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K211703Insignia Hip StemK191414EXETER Centralizer, EXETER 2.5mm PlugK173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsK173849Triathlon Total Knee SystemK172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemK153345Stryker Orthopaedics Hip Systems Labeling Update

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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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