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FDA 510(k)

HARRIER-SA™ Lumbar Interbody System

K-Number: K180519 · 2018-05-16

ApplicantChoicespine, LP
Decision Date2018-05-16
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HARRIER-SA™ Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2018-05-16 under 510(k) number K180519. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARRIER-SA™ Lumbar Interbody System?

HARRIER-SA™ Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2018-05-16. The listed applicant is Choicespine, LP. The 510(k) number is K180519.

When did HARRIER-SA™ Lumbar Interbody System receive FDA 510(k) clearance?

HARRIER-SA™ Lumbar Interbody System received FDA 510(k) clearance on 2018-05-16, under 510(k) number K180519.

Who is the listed applicant for HARRIER-SA™ Lumbar Interbody System?

The FDA 510(k) record lists Choicespine, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARRIER-SA™ Lumbar Interbody System?

The FDA product code for HARRIER-SA™ Lumbar Interbody System is OVD.

Other records listing Choicespine, LP as applicant

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.

K190227Boomerang™ Anterior Cervical Plate SystemK183397ChoiceSpine Stealth Cervical Spacer SystemK182721Choice Spine Navigation SystemK183214Raven Lumbar Plate SystemK172816TiGer Shark™ SystemK173215Choice Spine Laminoplasty™ Fixation System

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Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.

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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