CATALYSTEM Femoral Stems
K-Number: K240381 · 2024-06-27
ApplicantSmith & Nephew, Inc.
Decision Date2024-06-27
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 2024-06-27 under approval number K240381. 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 2024-06-27. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K240381.
When was CATALYSTEM Femoral Stems approved by the FDA?
CATALYSTEM Femoral Stems received FDA 510(k) clearance on 2024-06-27, under approval number K240381.
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.