FDA 510(k)

Harrier-SA Lumbar Interbody System

K-Number: K191367 · 2019-07-05

Decision Date2019-07-05

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Harrier-SA Lumbar Interbody System is a medical device manufactured by Choice Spine, LLC. It received FDA 510(k) clearance on 2019-07-05 under approval 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. It is manufactured by Choice Spine, LLC. The 510(k) number is K191367.

When was Harrier-SA Lumbar Interbody System approved by the FDA?

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

What company makes Harrier-SA Lumbar Interbody System?

Harrier-SA Lumbar Interbody System is manufactured by Choice Spine, LLC.

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

The FDA product code for Harrier-SA Lumbar Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Choice Spine, LLC

K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System K201643ChoiceSpine Tiger Shark Cervical Spacer System K211449Triton Sacroiliac Joint Fixation System K203311ChoiceSpine Blackhawk Ti Cervical Spacer System K203561ChoiceSpine Navigation System K220953ChoiceSpine TigerShark M, Modular Interbody System

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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.