CATALYSTEM Femoral Stems
K-Number: K250571 · 2025-03-28
ApplicantSmith & Nephew, Inc.
Decision Date2025-03-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CATALYSTEM Femoral Stems is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2025-03-28 under approval number K250571. 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 CATALYSTEM Femoral Stems?
CATALYSTEM Femoral Stems is a medical device that received FDA 510(k) clearance on 2025-03-28. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K250571.
When was CATALYSTEM Femoral Stems approved by the FDA?
CATALYSTEM Femoral Stems received FDA 510(k) clearance on 2025-03-28, under approval number K250571.
What company makes CATALYSTEM Femoral Stems?
CATALYSTEM Femoral Stems is manufactured by Smith & Nephew, Inc..
What is the FDA product code for CATALYSTEM Femoral Stems?
The FDA product code for CATALYSTEM Femoral Stems is LZO.
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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.