OTS Hip
K-Number: K232140 · 2024-03-11
ApplicantOrtoma AB
Decision Date2024-03-11
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
OTS Hip is a medical device manufactured by Ortoma AB. It received FDA 510(k) clearance on 2024-03-11 under approval number K232140. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OTS Hip?
OTS Hip is a medical device that received FDA 510(k) clearance on 2024-03-11. It is manufactured by Ortoma AB. The 510(k) number is K232140.
When was OTS Hip approved by the FDA?
OTS Hip received FDA 510(k) clearance on 2024-03-11, under approval number K232140.
What company makes OTS Hip?
OTS Hip is manufactured by Ortoma AB.
What is the FDA product code for OTS Hip?
The FDA product code for OTS Hip is OLO.
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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.