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FDA 510(k)

Ortoma Treatment Solution - OTS

K-Number: K181449 · 2018-09-19

ApplicantOrtoma AB
Decision Date2018-09-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ortoma Treatment Solution - OTS is the device name listed in this FDA 510(k) record. The listed applicant is Ortoma AB. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K181449. 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 Ortoma Treatment Solution - OTS?

Ortoma Treatment Solution - OTS is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Ortoma AB. The 510(k) number is K181449.

When did Ortoma Treatment Solution - OTS receive FDA 510(k) clearance?

Ortoma Treatment Solution - OTS received FDA 510(k) clearance on 2018-09-19, under 510(k) number K181449.

Who is the listed applicant for Ortoma Treatment Solution - OTS?

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 Ortoma Treatment Solution - OTS?

The FDA product code for Ortoma Treatment Solution - OTS 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.

K261852OTS HipK250086OTS HipK232140OTS Hip

Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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.

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