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FDA 510(k)

Harrier-SA Lumbar Interbody System

K-Number: K191367 · 2019-07-05

ApplicantChoice Spine, LLC
Decision Date2019-07-05
Product CodeMAX
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 Choice Spine, LLC. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K191367. The device is classified under product code MAX. 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 2019-07-05. The listed applicant is Choice Spine, LLC. The 510(k) number is K191367.

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

Harrier-SA Lumbar Interbody System received FDA 510(k) clearance on 2019-07-05, under 510(k) number K191367.

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

The FDA 510(k) record lists Choice Spine, LLC 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 MAX.

Other records listing Choice Spine, LLC 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.

K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemK220953ChoiceSpine TigerShark™ M, Modular Interbody SystemK220024ChoiceSpine Navigation SystemK211449Triton™ Sacroiliac Joint Fixation SystemK203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemK203561ChoiceSpine Navigation System

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Related Devices (Code: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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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