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FDA 510(k)

ROSA ONE Spine application

K-Number: K192173 · 2019-10-29

ApplicantMedtech S.A
Decision Date2019-10-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA ONE Spine application is the device name listed in this FDA 510(k) record. The listed applicant is Medtech S.A. It received FDA 510(k) clearance on 2019-10-29 under 510(k) number K192173. 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 ROSA ONE Spine application?

ROSA ONE Spine application is a medical device that received FDA 510(k) clearance on 2019-10-29. The listed applicant is Medtech S.A. The 510(k) number is K192173.

When did ROSA ONE Spine application receive FDA 510(k) clearance?

ROSA ONE Spine application received FDA 510(k) clearance on 2019-10-29, under 510(k) number K192173.

Who is the listed applicant for ROSA ONE Spine application?

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

What is the FDA product code for ROSA ONE Spine application?

The FDA product code for ROSA ONE Spine application is OLO.

Other records listing Medtech S.A 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.

K200511ROSA ONE Brain applicationK182848ROSA ONE Spine applicationK182417ROSA ONE Brain ApplicationK172444ROSA BRAIN (v3.0.0.5)K151511ROSA Spine

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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