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FDA 510(k)

OTS Hip

K-Number: K250086 · 2025-05-16

ApplicantOrtoma AB
Decision Date2025-05-16
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 2025-05-16 under approval number K250086. 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 2025-05-16. It is manufactured by Ortoma AB. The 510(k) number is K250086.

When was OTS Hip approved by the FDA?

OTS Hip received FDA 510(k) clearance on 2025-05-16, under approval number K250086.

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.

Other Devices by Ortoma AB

K181449Ortoma Treatment Solution - OTS K232140OTS Hip

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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.

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