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FDA 510(k)

ROSA Spine

K-Number: K151511 · 2016-01-04

ApplicantMedtech S.A
Decision Date2016-01-04
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA Spine 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 2016-01-04 under 510(k) number K151511. 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 Spine?

ROSA Spine is a medical device that received FDA 510(k) clearance on 2016-01-04. The listed applicant is Medtech S.A. The 510(k) number is K151511.

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

ROSA Spine received FDA 510(k) clearance on 2016-01-04, under 510(k) number K151511.

Who is the listed applicant for ROSA Spine?

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 Spine?

The FDA product code for ROSA Spine 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 applicationK192173ROSA ONE Spine applicationK182848ROSA ONE Spine applicationK182417ROSA ONE Brain ApplicationK172444ROSA BRAIN (v3.0.0.5)

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

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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