TiN Coated Humeral Head
K-Number: K191698 · 2020-07-16
ApplicantFx Shoulder USA, Inc.
Decision Date2020-07-16
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TiN Coated Humeral Head is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2020-07-16 under approval number K191698. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TiN Coated Humeral Head?
TiN Coated Humeral Head is a medical device that received FDA 510(k) clearance on 2020-07-16. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K191698.
When was TiN Coated Humeral Head approved by the FDA?
TiN Coated Humeral Head received FDA 510(k) clearance on 2020-07-16, under approval number K191698.
What company makes TiN Coated Humeral Head?
TiN Coated Humeral Head is manufactured by Fx Shoulder USA, Inc..
What is the FDA product code for TiN Coated Humeral Head?
The FDA product code for TiN Coated Humeral Head is KWT.
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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.