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FDA 510(k)

APEX K1 HIP STEM

K-Number: K110947 · 2011-06-16

ApplicantOmni Life Science, Inc.
Decision Date2011-06-16
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX K1 HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Omni Life Science, Inc.. It received FDA 510(k) clearance on 2011-06-16 under 510(k) number K110947. 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 K1 HIP STEM?

APEX K1 HIP STEM is a medical device that received FDA 510(k) clearance on 2011-06-16. The listed applicant is Omni Life Science, Inc.. The 510(k) number is K110947.

When did APEX K1 HIP STEM receive FDA 510(k) clearance?

APEX K1 HIP STEM received FDA 510(k) clearance on 2011-06-16, under 510(k) number K110947.

Who is the listed applicant for APEX K1 HIP STEM?

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

What is the FDA product code for APEX K1 HIP STEM?

The FDA product code for APEX K1 HIP STEM is LPH.

Other records listing Omni Life Science, Inc. 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.

K191765OMNI TiN Coated Apex Knee™ SystemK152919OMNI Skirted HeadsK131472APEX KNEE MODULAR TIBIA SYSTEMK112891APEX REVISION KNEE SYSTEMSK113242APEX ARC HIP STEMK111062APEX KNEE SYSTEM, APEX ALL POLY TIBIA

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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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