ONVOY Acetabular System
K-Number: K243456 · 2025-06-06
ApplicantGlobus Medical, Inc.
Decision Date2025-06-06
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 2025-06-06 under approval number K243456. 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 2025-06-06. It is manufactured by Globus Medical, Inc.. The 510(k) number is K243456.
When was ONVOY Acetabular System approved by the FDA?
ONVOY Acetabular System received FDA 510(k) clearance on 2025-06-06, under approval number K243456.
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.
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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.