FDA 510(k)

OTS Hip

K-Number: K261852 · 2026-07-01

Decision Date2026-07-01

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OTS Hip is the device name listed in this FDA 510(k) record. The listed applicant is Ortoma AB. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K261852. 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 2026-07-01. The listed applicant is Ortoma AB. The 510(k) number is K261852.

When did OTS Hip receive FDA 510(k) clearance?

OTS Hip received FDA 510(k) clearance on 2026-07-01, under 510(k) number K261852.

Who is the listed applicant for OTS Hip?

The FDA 510(k) record lists Ortoma AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTS Hip?

The FDA product code for OTS Hip is OLO.

Other records listing Ortoma AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250086OTS Hip K232140OTS Hip K181449Ortoma Treatment Solution - OTS

Related Devices (Code: OLO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.