Devices · Ortoma AB

OTS Hip

Ortoma AB is listed for OTS Hip (K250086). The FDA list gives May 16, 2025 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OLO as “Orthopedic Stereotaxic Instrument”: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250086

Official FDA database record

Date of final decision

May 16, 2025

Company on the FDA list

Ortoma AB

Lead panel

Neurology

Primary product code

OLO

openFDA device name for the code

Orthopedic Stereotaxic Instrument

Device class

2

Regulation number

882.4560

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary