Humelock TiN Coated Glenosphere
K-Number: K191146 · 2020-07-15
ApplicantFx Shoulder USA, Inc.
Decision Date2020-07-15
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Humelock TiN Coated Glenosphere is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2020-07-15 under approval number K191146. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Humelock TiN Coated Glenosphere?
Humelock TiN Coated Glenosphere is a medical device that received FDA 510(k) clearance on 2020-07-15. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K191146.
When was Humelock TiN Coated Glenosphere approved by the FDA?
Humelock TiN Coated Glenosphere received FDA 510(k) clearance on 2020-07-15, under approval number K191146.
What company makes Humelock TiN Coated Glenosphere?
Humelock TiN Coated Glenosphere is manufactured by Fx Shoulder USA, Inc..
What is the FDA product code for Humelock TiN Coated Glenosphere?
The FDA product code for Humelock TiN Coated Glenosphere is PHX.
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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.