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FDA 510(k)

APEX HCLA ACETABULAR CUP LINERS

K-Number: K062489 · 2007-08-15

ApplicantOmnilife Science
Decision Date2007-08-15
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX HCLA ACETABULAR CUP LINERS is the device name listed in this FDA 510(k) record. The listed applicant is Omnilife Science. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K062489. 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 HCLA ACETABULAR CUP LINERS?

APEX HCLA ACETABULAR CUP LINERS is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Omnilife Science. The 510(k) number is K062489.

When did APEX HCLA ACETABULAR CUP LINERS receive FDA 510(k) clearance?

APEX HCLA ACETABULAR CUP LINERS received FDA 510(k) clearance on 2007-08-15, under 510(k) number K062489.

Who is the listed applicant for APEX HCLA ACETABULAR CUP LINERS?

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

What is the FDA product code for APEX HCLA ACETABULAR CUP LINERS?

The FDA product code for APEX HCLA ACETABULAR CUP LINERS is LPH.

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Other records listing Omnilife Science 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.

K201611Apex Knee SystemK172467OMNI ARC Anteverted Neck Hip StemK171156OMNI Anseris Hip StemK163332Apex Revision Knee System

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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