HARRIER-SA™ Lumbar Interbody System

by Choicespine, LP

510(k) K180519

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

510(k) K180519↗

FDA record

Trust

Source FDA 510(k), synced 25 Oct 2026.

Overview

The HARRIER-SA Lumbar Interbody System is a traditional orthopedic device used for spinal fusion procedures. It features a unique lumbar interbody design, allowing for optimal fixation and stability in the spine. With its state-of-the-art materials and advanced technology, this device provides reliable and effective treatment for various orthopedic conditions.

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK180519	Date16 May 2018Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K180519

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K180519
FDA product code: OVD

Device class: Class II
Regulation: 21 CFR Part 888.3080
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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