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FDA 510(k)

APEX MODULAR HA HIP STEM

K-Number: K043123 · 2005-02-10

ApplicantApex Surgical, LLC
Decision Date2005-02-10
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX MODULAR HA HIP STEM 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 2005-02-10 under 510(k) number K043123. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX MODULAR HA HIP STEM?

APEX MODULAR HA HIP STEM is a medical device that received FDA 510(k) clearance on 2005-02-10. The listed applicant is Apex Surgical, LLC. The 510(k) number is K043123.

When did APEX MODULAR HA HIP STEM receive FDA 510(k) clearance?

APEX MODULAR HA HIP STEM received FDA 510(k) clearance on 2005-02-10, under 510(k) number K043123.

Who is the listed applicant for APEX MODULAR HA HIP STEM?

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 HA HIP STEM?

The FDA product code for APEX MODULAR HA HIP STEM is LPH.

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.

K041950APEX K2 HIP SYSTEMK031110APEX MODULAR ACETABULAR CUPK012918APEX MODULAR ALUMINA FEMORAL HEADK003923APEX MODULAR ZIRCONIA FEMORAL HEADK000788APEX MODULAR HIP STEM

Related Devices (Code: LPH)

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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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