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FDA 510(k)

OMNI ARC Anteverted Neck Hip Stem

K-Number: K172467 · 2017-12-21

ApplicantOmnilife Science
Decision Date2017-12-21
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNI ARC Anteverted Neck Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Omnilife Science. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K172467. 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 OMNI ARC Anteverted Neck Hip Stem?

OMNI ARC Anteverted Neck Hip Stem is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Omnilife Science. The 510(k) number is K172467.

When did OMNI ARC Anteverted Neck Hip Stem receive FDA 510(k) clearance?

OMNI ARC Anteverted Neck Hip Stem received FDA 510(k) clearance on 2017-12-21, under 510(k) number K172467.

Who is the listed applicant for OMNI ARC Anteverted Neck Hip Stem?

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 OMNI ARC Anteverted Neck Hip Stem?

The FDA product code for OMNI ARC Anteverted Neck Hip Stem is LZO.

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 SystemK171156OMNI Anseris Hip StemK163332Apex Revision Knee System

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.

K261009MobileLink 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 GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, 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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