U2 Femoral Head
K-Number: K162957 · 2017-07-17
ApplicantUnited Orthopedic Corporation
Decision Date2017-07-17
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
U2 Femoral Head is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2017-07-17 under approval number K162957. 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 U2 Femoral Head?
U2 Femoral Head is a medical device that received FDA 510(k) clearance on 2017-07-17. It is manufactured by United Orthopedic Corporation. The 510(k) number is K162957.
When was U2 Femoral Head approved by the FDA?
U2 Femoral Head received FDA 510(k) clearance on 2017-07-17, under approval number K162957.
What company makes U2 Femoral Head?
U2 Femoral Head is manufactured by United Orthopedic Corporation.
What is the FDA product code for U2 Femoral Head?
The FDA product code for U2 Femoral Head 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.