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FDA 510(k)

Navigation Enabled Intruments

K-Number: K200791 · 2020-07-31

ApplicantMedos International SARL
Decision Date2020-07-31
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigation Enabled Intruments is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K200791. 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 Navigation Enabled Intruments?

Navigation Enabled Intruments is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Medos International SARL. The 510(k) number is K200791.

When did Navigation Enabled Intruments receive FDA 510(k) clearance?

Navigation Enabled Intruments received FDA 510(k) clearance on 2020-07-31, under 510(k) number K200791.

Who is the listed applicant for Navigation Enabled Intruments?

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

What is the FDA product code for Navigation Enabled Intruments?

The FDA product code for Navigation Enabled Intruments is OLO.

Related Clinical Trials

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Other records listing Medos International SARL 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.

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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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