Conformity stem, cemented
K-Number: K191056 · 2020-01-03
ApplicantUnited Orthopedic Corporation
Decision Date2020-01-03
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Conformity stem, cemented is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2020-01-03 under approval number K191056. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Conformity stem, cemented?
Conformity stem, cemented is a medical device that received FDA 510(k) clearance on 2020-01-03. It is manufactured by United Orthopedic Corporation. The 510(k) number is K191056.
When was Conformity stem, cemented approved by the FDA?
Conformity stem, cemented received FDA 510(k) clearance on 2020-01-03, under approval number K191056.
What company makes Conformity stem, cemented?
Conformity stem, cemented is manufactured by United Orthopedic Corporation.
What is the FDA product code for Conformity stem, cemented?
The FDA product code for Conformity stem, cemented is JDI.
Other Devices by United Orthopedic Corporation
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K153216Alpine Cemented Hip SystemOrtho Development Corporation
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K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.
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.