U2 Bipolar Implant and 22mm Femoral Head
K-Number: K152439 · 2016-04-07
ApplicantUnited Orthopedic Corporation
Decision Date2016-04-07
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
U2 Bipolar Implant and 22mm Femoral Head is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2016-04-07 under approval number K152439. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the U2 Bipolar Implant and 22mm Femoral Head?
U2 Bipolar Implant and 22mm Femoral Head is a medical device that received FDA 510(k) clearance on 2016-04-07. It is manufactured by United Orthopedic Corporation. The 510(k) number is K152439.
When was U2 Bipolar Implant and 22mm Femoral Head approved by the FDA?
U2 Bipolar Implant and 22mm Femoral Head received FDA 510(k) clearance on 2016-04-07, under approval number K152439.
What company makes U2 Bipolar Implant and 22mm Femoral Head?
U2 Bipolar Implant and 22mm Femoral Head is manufactured by United Orthopedic Corporation.
What is the FDA product code for U2 Bipolar Implant and 22mm Femoral Head?
The FDA product code for U2 Bipolar Implant and 22mm Femoral Head is KWY.
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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.