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FDA 510(k)

APEX K2 HIP SYSTEM

K-Number: K041950 · 2004-12-21

ApplicantApex Surgical, LLC
Decision Date2004-12-21
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX K2 HIP SYSTEM 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 2004-12-21 under 510(k) number K041950. 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 K2 HIP SYSTEM?

APEX K2 HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-21. The listed applicant is Apex Surgical, LLC. The 510(k) number is K041950.

When did APEX K2 HIP SYSTEM receive FDA 510(k) clearance?

APEX K2 HIP SYSTEM received FDA 510(k) clearance on 2004-12-21, under 510(k) number K041950.

Who is the listed applicant for APEX K2 HIP SYSTEM?

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 K2 HIP SYSTEM?

The FDA product code for APEX K2 HIP SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 STEMK031110APEX 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

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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