Coated hip implants
K-Number: K250450 · 2025-09-19
ApplicantMedacta International S.A.
Decision Date2025-09-19
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Coated hip implants is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-09-19 under approval number K250450. 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 Coated hip implants?
Coated hip implants is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Medacta International S.A.. The 510(k) number is K250450.
When was Coated hip implants approved by the FDA?
Coated hip implants received FDA 510(k) clearance on 2025-09-19, under approval number K250450.
What company makes Coated hip implants?
Coated hip implants is manufactured by Medacta International S.A..
What is the FDA product code for Coated hip implants?
The FDA product code for Coated hip implants is LZO.
Related Clinical Trials
Other Devices by Medacta International S.A.
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K152893Corin Optimized Positioning System (OPS)Corin USA
K160289MasterLoc StemMedacta International
K152903REVIVAL(TM) Modular Revision Hip StemCorin USA
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.