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FDA 510(k)

FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments

K-Number: K243659 · 2025-04-02

ApplicantSeaSpine Orthopedics Corporation
Decision Date2025-04-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2025-04-02 under approval number K243659. 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 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments?

FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments is a medical device that received FDA 510(k) clearance on 2025-04-02. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K243659.

When was FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments approved by the FDA?

FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments received FDA 510(k) clearance on 2025-04-02, under approval number K243659.

What company makes FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments?

FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments?

The FDA product code for FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments is OLO.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING

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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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