FDA 510(k)

FLASH® 骨突融合工具，IsoTis® 骨突融合工具

K号: K243659 · 2025-04-02

决定日期2025-04-02

产品代码OLO

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决定实质等同

器械摘要

FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K243659. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K243659.

When did FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

列明SeaSpine Orthopedics Corporation为申报人的其他记录

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