Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

APEX ARC HIP STEM

K-Number: K111193 · 2011-06-27

ApplicantOmni Life Science, Inc.
Decision Date2011-06-27
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX ARC 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 2011-06-27 under 510(k) number K111193. 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 APEX ARC HIP STEM?

APEX ARC HIP STEM is a medical device that received FDA 510(k) clearance on 2011-06-27. The listed applicant is Omni Life Science, Inc.. The 510(k) number is K111193.

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

APEX ARC HIP STEM received FDA 510(k) clearance on 2011-06-27, under 510(k) number K111193.

Who is the listed applicant for APEX ARC 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 ARC HIP STEM?

The FDA product code for APEX ARC HIP STEM is LZO.

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

View all 21 devices →

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.

↑