TransLoc 3D
K-Number: K232878 · 2023-10-17
Decision Date2023-10-17
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TransLoc 3D is a medical device manufactured by Foundation Fusion Solutions, LLC (Dba Cornerloc). It received FDA 510(k) clearance on 2023-10-17 under approval number K232878. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TransLoc 3D?
TransLoc 3D is a medical device that received FDA 510(k) clearance on 2023-10-17. It is manufactured by Foundation Fusion Solutions, LLC (Dba Cornerloc). The 510(k) number is K232878.
When was TransLoc 3D approved by the FDA?
TransLoc 3D received FDA 510(k) clearance on 2023-10-17, under approval number K232878.
What company makes TransLoc 3D?
TransLoc 3D is manufactured by Foundation Fusion Solutions, LLC (Dba Cornerloc).
What is the FDA product code for TransLoc 3D?
The FDA product code for TransLoc 3D is OUR.
Other Devices by Foundation Fusion Solutions, LLC (Dba Cornerloc)
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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.