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FDA 510(k)

ONVOY Acetabular System

K-Number: K213842 · 2022-10-03

ApplicantGlobus Medical, Inc.
Decision Date2022-10-03
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ONVOY Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2022-10-03 under 510(k) number K213842. 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 ONVOY Acetabular System?

ONVOY Acetabular System is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Globus Medical, Inc.. The 510(k) number is K213842.

When did ONVOY Acetabular System receive FDA 510(k) clearance?

ONVOY Acetabular System received FDA 510(k) clearance on 2022-10-03, under 510(k) number K213842.

Who is the listed applicant for ONVOY Acetabular System?

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

What is the FDA product code for ONVOY Acetabular System?

The FDA product code for ONVOY Acetabular System is LPH.

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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.

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.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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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