EMPHASYS Femoral Stems
K-Number: K211657 · 2021-08-05
ApplicantDepuy Ireland UC
Decision Date2021-08-05
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EMPHASYS Femoral Stems is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2021-08-05 under approval number K211657. 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 EMPHASYS Femoral Stems?
EMPHASYS Femoral Stems is a medical device that received FDA 510(k) clearance on 2021-08-05. It is manufactured by Depuy Ireland UC. The 510(k) number is K211657.
When was EMPHASYS Femoral Stems approved by the FDA?
EMPHASYS Femoral Stems received FDA 510(k) clearance on 2021-08-05, under approval number K211657.
What company makes EMPHASYS Femoral Stems?
EMPHASYS Femoral Stems is manufactured by Depuy Ireland UC.
What is the FDA product code for EMPHASYS Femoral Stems?
The FDA product code for EMPHASYS 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.