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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 the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems. It received FDA 510(k) clearance on 2020-01-17 under 510(k) 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. The listed applicant is Osseus Fusion Systems. The 510(k) number is K192495.

When did Black Diamond Navigation Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for Black Diamond Navigation Instruments?

The FDA 510(k) record lists Osseus Fusion Systems as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Osseus Fusion Systems as applicant

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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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