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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 a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2022-10-03 under approval 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. It is manufactured by Globus Medical, Inc.. The 510(k) number is K213842.

When was ONVOY Acetabular System approved by the FDA?

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

What company makes ONVOY Acetabular System?

ONVOY Acetabular System is manufactured by Globus Medical, Inc..

What is the FDA product code for ONVOY Acetabular System?

The FDA product code for ONVOY Acetabular System is LPH.

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Other Devices by Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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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