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FDA 510(k)

Black Diamond Navigation Instruments

K-Number: K192495 · 2020-01-17

ApplicantOsseus Fusion Systems
Decision Date2020-01-17
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Black Diamond Navigation Instruments is a medical device manufactured by Osseus Fusion Systems. It received FDA 510(k) clearance on 2020-01-17 under approval number K192495. 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 Black Diamond Navigation Instruments?

Black Diamond Navigation Instruments is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Osseus Fusion Systems. The 510(k) number is K192495.

When was Black Diamond Navigation Instruments approved by the FDA?

Black Diamond Navigation Instruments received FDA 510(k) clearance on 2020-01-17, under approval number K192495.

What company makes Black Diamond Navigation Instruments?

Black Diamond Navigation Instruments is manufactured by Osseus Fusion Systems.

What is the FDA product code for Black Diamond Navigation Instruments?

The FDA product code for Black Diamond Navigation Instruments is OLO.

Related Clinical Trials

NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

Other Devices by Osseus Fusion Systems

K192121Black Diamond Pedicle Screw System K222107Black Diamond™ POCT Spinal System K213935PISCES-SA Standalone ALIF Interbody System K223413Pisces™-SA STANDALONE ALIF Interbody System

Related Devices (Code: OLO)

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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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